NEUROVENT: Implementation of Neuro Lung Protective Ventilation

Sponsor
Colin Grissom (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03243539
Collaborator
(none)
728
1
1
52
14

Study Details

Study Description

Brief Summary

Patients who experience lung injury are often placed on a ventilator to help them heal; however, if the ventilator volume settings are too high, it can cause additional lung injury. It is proven that using lower ventilator volume settings improves outcomes. In patients with acute brain injury, it is proven that maintaining a normal partial pressure of carbon dioxide in the arterial blood improves outcomes. Mechanical ventilator settings with higher volumes and higher breathing rates are sometimes required to maintain a normal partial pressure of carbon dioxide. These 2 goals of mechanical ventilation, using lower volumes to prevent additional lung injury but maintaining a normal partial pressure of carbon dioxide, are both important for patients with acute brain injury. The investigators have designed a computerized ventilator protocol in iCentra that matches the current standard of care for mechanical ventilation of patients with acute brain injury by targeting a normal partial pressure of carbon dioxide with the lowest ventilator volume required.

This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a standard of care mechanical ventilation protocol for patients with acute brain injury in the iCentra electronic medical record system at Intermountain Medical Center. We hypothesize that implementation of a standardized neuro lung protective ventilation protocol will be feasible, will achieve a target normal partial pressure of carbon dioxide, will decrease tidal volumes toward the target 6 mL/kg predicted body weight, and will improve outcomes.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Lung Protective Ventilation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
728 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Implementation of Neuro Lung Protective Ventilation in Patients With Acute Brain Injury
Actual Study Start Date :
Aug 31, 2017
Actual Primary Completion Date :
Dec 31, 2018
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lung Protective Ventilation

Subjects with acute brain injury (traumatic brain injury and non-traumatic brain injury) will receive neuro lung protective ventilation which targets a normal arterial partial pressure of carbon dioxide with the lowest tidal volume possible (6 to 8 ml/kg predicted body weight). Protocols for oxygenation and weaning from the ventilator will also be followed.

Procedure: Lung Protective Ventilation
Neuro lung protective ventilation for patients with acute brain injury is designed to target a normal partial pressure of arterial carbon dioxide and decrease initial tidal volumes toward a target 6 ml/kg predicted body weight PBW (range 6 to 8 ml/kg PBW)

Outcome Measures

Primary Outcome Measures

  1. Patient-Level Proportion of time on Mechanical Ventilation with a Tidal Volume <= 6.5 ml/kg PBW [Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days]

Secondary Outcome Measures

  1. Proportion of time with a target PaCO2 of 35 to 45 mm Hg [Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days]

  2. Average number of protocol deviations for all subjects (protocol compliance) [Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days]

    Average of the number of instances in which the procedures specified in the protocol were not followed for each enrolled subject

  3. Hospital Discharge Disposition [Day of hospital discharge, an average of 10 days after admission]

    Routine, skilled nursing facility, home health, other

  4. Hospital, 28-Day, and 90-Day Mortality [Hospital admission through 90 days]

  5. Ventilator-free days to day 28 [Initiation of mechanical ventilation to day 28]

  6. Time to First ICU Activity [Day of admission to day of first ICU activity, an average of 0.2 days]

  7. Hospital, ICU Length of Stay [Day of admission to day of discharge, an average of 10 days]

  8. Health Care Utilization [Day of admission to day of discharge, an average of 10 days]

    Number of procedures/surgeries while in the hospital and number of days of hospitalization

  9. Quality of Life [Day of admission until up to 1 year after day of discharge]

    May include SF-36 or similar measures

  10. Costs of Care [Day of admission to day of discharge, an average of 10 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Acute brain injury due to non-traumatic causes (stroke, spontaneous intracranial hemorrhage, cerebral edema, anoxic brain injury) or traumatic brain injury.

  2. Initiation of mechanical ventilation in the emergency department or intensive care unit at an Intermountain Healthcare hospital

  3. Age ≥ 18 years

Exclusion Criteria:
  1. Transition to comfort care in the emergency department or on the same day of admission to the ICU

  2. Death on the same day of admission to the emergency department or ICU

Contacts and Locations

Locations

Site City State Country Postal Code
1 Intermountain Medical Center Murray Utah United States 84107

Sponsors and Collaborators

  • Colin Grissom

Investigators

  • Principal Investigator: Colin K Grissom, MD, Intermountain Health Care, Inc.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Colin Grissom, Co-Medical Director Shock Trauma ICU, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT03243539
Other Study ID Numbers:
  • 1050582
First Posted:
Aug 9, 2017
Last Update Posted:
Feb 25, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Colin Grissom, Co-Medical Director Shock Trauma ICU, Intermountain Health Care, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 25, 2021