Pain, Agitation and Delirium (PAD) Protocol in the Duke CICU
Study Details
Study Description
Brief Summary
This study aims to examine the use of protocol directed sedation using the Duke PAD protocol with the current sedation medications of propofol or dexmedetomidine compared to the PAD protocol with midazolam, per cardiac intensive care unit (CICU) usual care, as an initial step toward understanding the best management of sedation in these patients.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Detailed Description
The optimal approach to management of sedation in the Intensive Care Unit (ICU) has become a topic of increasing interest. The most recent guidelines outline the pharmacologic mechanisms of commonly used medications as well as scales on which to measure goals of pain, sedation, agitation and delirium in the critically ill patient. This guideline is based on a cadre of randomized controlled trials examining the medications in the medical intensive care unit and post cardiac surgery patient. Notably, in each of the trials, patients presenting with acute myocardial infarction, heart failure or cardiogenic shock have been excluded or largely underrepresented.
Using the current guidelines as a foundation, a new pain, agitation and delirium (PAD) protocol, which prioritizes the use of propofol or dexmedetomidine for sedation, was developed and instituted at Duke University Hospital. However, use of this protocol in the CICU has raised important considerations. Some of these stem from the specific hemodynamic characteristics of the population, including significant bradycardia and hypotension, which can be worsened due to known side effects of propofol and dexmedetomidine. It remains unclear whether the benefits of these medications outweigh the risks in CICU patients as the use of these medications has not been studied previously in this population. This study aims to examine the use of protocol directed sedation using the Duke PAD protocol with the current sedation medications of propofol or dexmedetomidine compared to the PAD protocol with midazolam, per CICU usual care, as an initial step toward understanding the best management of sedation in these patients.
Project Aims Include:
-
Examine the efficacy of the PAD protocol using propofol or dexmedetomidine versus midazolam with regard to goal sedation, pain control and level of delirium in intubated Duke CICU patients.
-
Determine differences in duration of ventilator days, CICU stay and total hospital stay with the PAD protocol using propofol or dexmedetomidine compared to midazolam in the Duke CICU.
-
Compare the rates of adverse effects of the current PAD protocol with propofol or dexmedetomidine versus midazolam for sedation in the Duke CICU, including hypotension, bradycardia, difficulty with ventilator weaning due to sedation, and delirium.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Midazolam IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. |
Drug: Midazolam
IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Other Names:
|
Active Comparator: Propofol or Dexmedetomidine Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. |
Drug: Propofol
IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Other Names:
Drug: Dexmedetomidine
IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Intensive Care Unit Length of Stay [One month or hospital discharge, whichever time point comes first]
Number of days of admission to the CICU during the index hospitalization
Secondary Outcome Measures
- In Hospital Mortality [One month or hospital discharge, whichever time point comes first]
All-cause mortality during the hospitalization
- Hospital Length of Stay [One month or hospital discharge, whichever time point comes first]
Index hospitalization length of stay in days
- Number of Participants With Increased Vasopressor Requirement [One month or hospital discharge, whichever time point comes first]
Patients will be monitored for increased pressor requirement during the CICU stay
- Number of Participants With Bradycardia [One month or hospital discharge, whichever time point comes first]
Patients will be monitored for bradycardia which may be associated with sedation drug. Average heart rate before, during and after use of drug will be recorded for each patient.
- Number of Ventilator Days [One month or hospital discharge, whichever time point comes first]
Days requiring mechanical ventilation during the initial episode of intubation during the hospitalization
- Number of Days From Decision to Extubate to True Extubation [One month or hospital discharge, whichever time point comes first]
The time (in days) from when the clinical care team documents a decision to pursue extubation until the time the patient was extubated
- Number of Days Alive During Admission and Free From Delirium or Coma [One month or hospital discharge, whichever time point comes first]
The number of days alive and free from delirium or coma during admission will be evaluated among patients with CAM-ICU documented
- Percentage of Time at Goal Sedation [One month or hospital discharge, whichever time point comes first]
Will use RASS (Richmond Agitation and Sedation Scale) to assess level of sedation as per standard of care by nurses in the CICU. Data that is recorded will be evaluated following discharge. The RASS ranges from -5 (unrousable) to +4 (combative) and 0 (zero) = alert and calm and goal sedation is considered a RASS level of 0 to -2.
- Time From Withdrawal of Sedation to ICU Discharge [One month or hospital discharge, whichever time point comes first]
The duration, in days, from withdrawal of sedation for mechanical ventilation until the time of discharge from the ICU
- Number of Participants With Delirium [One month or hospital discharge, whichever time point comes first]
Will use the Confusion Assessment Method for the ICU (CAM-ICU) to assess presence of delirium as per standard of care by nurses in the CICU. Patients with CAM-ICU data recorded will be included.
- Pain Management [One month or hospital discharge, whichever time point comes first]
Will use the CPOT (Critical-Care Pain Observation Tool) score to assess pain level as per standard of care by nurses in the CICU. The CPOT has a range of 0 to 8. A CPOT score of ≤ 2 = minimal to no pain present and >2 = unacceptable level of pain. Data that is recorded will be evaluated following discharge.
- Number of Participants Requiring Reintubation [One month or hospital discharge, whichever time point comes first]
Following ICU discharge, patient charts will be reviewed to evaluate whether they required reintubation. If so, will determine whether necessity of reintubation was related to delirium.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
All patients admitted to the Duke CICU, who require intubation and sedation for mechanical ventilation that is expected to be >24 hours in duration will be included, unless they meet the specified exclusion criteria.
-
Patients intubated within one hour prior to care transition to the CICU will also be screened for inclusion.
Exclusion Criteria:
-
Exclusion criteria include patients following resuscitation from cardiac arrest who are treated on the cooling protocol
-
patients who have suffered a neurologic event (seizure, stroke) or who have baseline dementia, both of which could limit delirium assessment
-
patients with child class B and C liver disease
-
patients with known allergy to study medications.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Duke University
Investigators
- Principal Investigator: Kristin Newby, MD, Duke University
Study Documents (Full-Text)
More Information
Publications
- Barr J, Fraser GL, Puntillo K, Ely EW, Gélinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72. Review.
- Carson SS, Kress JP, Rodgers JE, Vinayak A, Campbell-Bright S, Levitt J, Bourdet S, Ivanova A, Henderson AG, Pohlman A, Chang L, Rich PB, Hall J. A randomized trial of intermittent lorazepam versus propofol with daily interruption in mechanically ventilated patients. Crit Care Med. 2006 May;34(5):1326-32.
- Hall RI, Sandham D, Cardinal P, Tweeddale M, Moher D, Wang X, Anis AH; Study Investigators. Propofol vs midazolam for ICU sedation : a Canadian multicenter randomized trial. Chest. 2001 Apr;119(4):1151-9.
- Huey-Ling L, Chun-Che S, Jen-Jen T, Shau-Ting L, Hsing-I C. Comparison of the effect of protocol-directed sedation with propofol vs. midazolam by nurses in intensive care: efficacy, haemodynamic stability and patient satisfaction. J Clin Nurs. 2008 Jun;17(11):1510-7. doi: 10.1111/j.1365-2702.2007.02128.x.
- Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedetomidine for Long-Term Sedation Investigators. Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA. 2012 Mar 21;307(11):1151-60. doi: 10.1001/jama.2012.304.
- Pandharipande PP, Sanders RD, Girard TD, McGrane S, Thompson JL, Shintani AK, Herr DL, Maze M, Ely EW; MENDS investigators. Effect of dexmedetomidine versus lorazepam on outcome in patients with sepsis: an a priori-designed analysis of the MENDS randomized controlled trial. Crit Care. 2010;14(2):R38. doi: 10.1186/cc8916. Epub 2010 Mar 16. Erratum in: Crit Care. 2011;15(1):402.
- Riker RR, Shehabi Y, Bokesch PM, Ceraso D, Wisemandle W, Koura F, Whitten P, Margolis BD, Byrne DW, Ely EW, Rocha MG; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009 Feb 4;301(5):489-99. doi: 10.1001/jama.2009.56. Epub 2009 Feb 2.
- Searle NR, Côté S, Taillefer J, Carrier M, Gagnon L, Roy M, Lussier D. Propofol or midazolam for sedation and early extubation following cardiac surgery. Can J Anaesth. 1997 Jun;44(6):629-35.
- Pro00074866
Study Results
Participant Flow
Recruitment Details | Patients were recruited from the Duke CICU between September 1, 2017 and June 30, 2019. Patients were identified by the rounding team for potential inclusion in the sedation trial and then screened by study team members to determine whether they met inclusion criteria. Consent was obtained from eligible patient's primary decision maker. |
---|---|
Pre-assignment Detail | No enrolled participants were excluded from the study prior to group assignment. |
Arm/Group Title | Midazolam | Propofol or Dexmedetomidine |
---|---|---|
Arm/Group Description | IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. |
Period Title: Overall Study | ||
STARTED | 4 | 3 |
COMPLETED | 4 | 3 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Midazolam | Propofol or Dexmedetomidine | Total |
---|---|---|---|
Arm/Group Description | IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Total of all reporting groups |
Overall Participants | 4 | 3 | 7 |
Age (years) [Median (Inter-Quartile Range) ] | |||
Median (Inter-Quartile Range) [years] |
72.5
|
57.0
|
70.0
|
Sex: Female, Male (Count of Participants) | |||
Female |
2
50%
|
3
100%
|
5
71.4%
|
Male |
2
50%
|
0
0%
|
2
28.6%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
1
25%
|
1
33.3%
|
2
28.6%
|
White |
3
75%
|
2
66.7%
|
5
71.4%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | |||
United States |
4
100%
|
3
100%
|
7
100%
|
BMI (kg/m^2) [Median (Inter-Quartile Range) ] | |||
Median (Inter-Quartile Range) [kg/m^2] |
36.1
|
34.4
|
34.4
|
Ejection Fraction (Percentage of blood) [Median (Inter-Quartile Range) ] | |||
Median (Inter-Quartile Range) [Percentage of blood] |
30.0
|
55.0
|
40.0
|
Outcome Measures
Title | Intensive Care Unit Length of Stay |
---|---|
Description | Number of days of admission to the CICU during the index hospitalization |
Time Frame | One month or hospital discharge, whichever time point comes first |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Midazolam | Propofol or Dexmedetomidine |
---|---|---|
Arm/Group Description | IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. |
Measure Participants | 4 | 3 |
Median (Inter-Quartile Range) [Days] |
4.1
|
10.0
|
Title | In Hospital Mortality |
---|---|
Description | All-cause mortality during the hospitalization |
Time Frame | One month or hospital discharge, whichever time point comes first |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Midazolam | Propofol or Dexmedetomidine |
---|---|---|
Arm/Group Description | IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. |
Measure Participants | 4 | 3 |
Number [participants] |
1
25%
|
1
33.3%
|
Title | Hospital Length of Stay |
---|---|
Description | Index hospitalization length of stay in days |
Time Frame | One month or hospital discharge, whichever time point comes first |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Midazolam | Propofol or Dexmedetomidine |
---|---|---|
Arm/Group Description | IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. |
Measure Participants | 4 | 3 |
Median (Inter-Quartile Range) [Days] |
19.5
|
30.0
|
Title | Number of Participants With Increased Vasopressor Requirement |
---|---|
Description | Patients will be monitored for increased pressor requirement during the CICU stay |
Time Frame | One month or hospital discharge, whichever time point comes first |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Midazolam | Propofol or Dexmedetomidine |
---|---|---|
Arm/Group Description | IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. |
Measure Participants | 4 | 3 |
Count of Participants [Participants] |
2
50%
|
2
66.7%
|
Title | Number of Participants With Bradycardia |
---|---|
Description | Patients will be monitored for bradycardia which may be associated with sedation drug. Average heart rate before, during and after use of drug will be recorded for each patient. |
Time Frame | One month or hospital discharge, whichever time point comes first |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Midazolam | Propofol or Dexmedetomidine |
---|---|---|
Arm/Group Description | IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. |
Measure Participants | 4 | 3 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Title | Number of Ventilator Days |
---|---|
Description | Days requiring mechanical ventilation during the initial episode of intubation during the hospitalization |
Time Frame | One month or hospital discharge, whichever time point comes first |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Midazolam | Propofol or Dexmedetomidine |
---|---|---|
Arm/Group Description | IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. |
Measure Participants | 4 | 3 |
Median (Inter-Quartile Range) [Days] |
2.5
|
6.8
|
Title | Number of Days From Decision to Extubate to True Extubation |
---|---|
Description | The time (in days) from when the clinical care team documents a decision to pursue extubation until the time the patient was extubated |
Time Frame | One month or hospital discharge, whichever time point comes first |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Midazolam | Propofol or Dexmedetomidine |
---|---|---|
Arm/Group Description | IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. |
Measure Participants | 4 | 3 |
Median (Inter-Quartile Range) [Days] |
0
|
0
|
Title | Number of Days Alive During Admission and Free From Delirium or Coma |
---|---|
Description | The number of days alive and free from delirium or coma during admission will be evaluated among patients with CAM-ICU documented |
Time Frame | One month or hospital discharge, whichever time point comes first |
Outcome Measure Data
Analysis Population Description |
---|
CAM-ICU was only documented in 3/7 of the patients enrolled, all of whom were in the midazolam arm of the study. Only these patients were included in this analysis. |
Arm/Group Title | Midazolam | Propofol or Dexmedetomidine |
---|---|---|
Arm/Group Description | IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. |
Measure Participants | 3 | 0 |
Median (Inter-Quartile Range) [Days] |
14.0
|
Title | Percentage of Time at Goal Sedation |
---|---|
Description | Will use RASS (Richmond Agitation and Sedation Scale) to assess level of sedation as per standard of care by nurses in the CICU. Data that is recorded will be evaluated following discharge. The RASS ranges from -5 (unrousable) to +4 (combative) and 0 (zero) = alert and calm and goal sedation is considered a RASS level of 0 to -2. |
Time Frame | One month or hospital discharge, whichever time point comes first |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Midazolam | Propofol or Dexmedetomidine |
---|---|---|
Arm/Group Description | IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. |
Measure Participants | 4 | 3 |
Median (Inter-Quartile Range) [percentage of time] |
63.3
|
63.2
|
Title | Time From Withdrawal of Sedation to ICU Discharge |
---|---|
Description | The duration, in days, from withdrawal of sedation for mechanical ventilation until the time of discharge from the ICU |
Time Frame | One month or hospital discharge, whichever time point comes first |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Midazolam | Propofol or Dexmedetomidine |
---|---|---|
Arm/Group Description | IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. |
Measure Participants | 4 | 3 |
Median (Inter-Quartile Range) [Days] |
1.6
|
5.6
|
Title | Number of Participants With Delirium |
---|---|
Description | Will use the Confusion Assessment Method for the ICU (CAM-ICU) to assess presence of delirium as per standard of care by nurses in the CICU. Patients with CAM-ICU data recorded will be included. |
Time Frame | One month or hospital discharge, whichever time point comes first |
Outcome Measure Data
Analysis Population Description |
---|
Patients with CAM-ICU score documented in the CICU (3/7 participants, all in the midazolam arm of the study) |
Arm/Group Title | Midazolam | Propofol or Dexmedetomidine |
---|---|---|
Arm/Group Description | IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. |
Measure Participants | 3 | 0 |
Count of Participants [Participants] |
1
25%
|
Title | Pain Management |
---|---|
Description | Will use the CPOT (Critical-Care Pain Observation Tool) score to assess pain level as per standard of care by nurses in the CICU. The CPOT has a range of 0 to 8. A CPOT score of ≤ 2 = minimal to no pain present and >2 = unacceptable level of pain. Data that is recorded will be evaluated following discharge. |
Time Frame | One month or hospital discharge, whichever time point comes first |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Midazolam | Propofol or Dexmedetomidine |
---|---|---|
Arm/Group Description | IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. |
Measure Participants | 4 | 3 |
Median (Inter-Quartile Range) [score on a scale] |
0.0
|
0.0
|
Title | Number of Participants Requiring Reintubation |
---|---|
Description | Following ICU discharge, patient charts will be reviewed to evaluate whether they required reintubation. If so, will determine whether necessity of reintubation was related to delirium. |
Time Frame | One month or hospital discharge, whichever time point comes first |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Midazolam | Propofol or Dexmedetomidine |
---|---|---|
Arm/Group Description | IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. |
Measure Participants | 4 | 3 |
Count of Participants [Participants] |
0
0%
|
1
33.3%
|
Adverse Events
Time Frame | From time of enrollment to hospital discharge - a range of 2-29 days for the patients enrolled in the trial | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Midazolam | Propofol or Dexmedetomidine | ||
Arm/Group Description | IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline. Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2. | ||
All Cause Mortality |
||||
Midazolam | Propofol or Dexmedetomidine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/4 (25%) | 1/3 (33.3%) | ||
Serious Adverse Events |
||||
Midazolam | Propofol or Dexmedetomidine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/4 (0%) | 0/3 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Midazolam | Propofol or Dexmedetomidine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/4 (0%) | 0/3 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Angela Lowenstern |
---|---|
Organization | Duke University |
Phone | 919-684-0111 |
angela.sandelin@duke.edu |
- Pro00074866