Sedation Optimisation Strategy (S.O.S.) Ventilation

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Completed
• CT.gov ID: NCT01486121
• Collaborator: (none)
• Enrollment: 140
• Locations: 3
• Arms: 2
• Duration (Months): 40
• Patients Per Site: 46.7
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

Use of sedatives and analgesics is common in mechanically ventilated patients hospitalized in Intensive Care Unit (ICU). That is called " sedation " and aimed to reduce both pain and anxiety and also to allow an effective and atraumatic mechanical ventilation. However, sedation excess and ventilator support excess, both in duration and intensity, are associated with an excess morbidity. Patients usually are systematically sedated after having been intubated. Then, sedation is stopped first before ventilator support is weaning. Several studies shown that rationalized protocols of sedation and ventilation orderings had a beneficial impact on non surgical patients' outcome. Feasibility of these protocols in surgical patients is still unknown. Moreover, no study has evaluated an optimized paired strategy of sedation-ventilation based on the priority setting of ventilation. This priority setting of ventilation should increase patient's comfort in spite of increasing sedatives and analgesics dosing. An paired sedation-ventilation protocol optimized for both duration and intensity of these treatments could improve surgical patients' outcome in ICU.

Condition or Disease	Intervention/Treatment	Phase
Surgery; Critical Illness; Mechanical Ventilation Complication; Organ Dysfunction Syndrome; Intensive Care Unit Syndrome	Other: Therapy strategy	Phase 3

Detailed Description

Intervention group:

• Continuous use of sedatives and analgesics (commonly called "sedation") will be stopped upon enrolment.

• Ventilator asynchrony in Volume assist Controlled Ventilation (VCV) will be treated by switching to Pressure Support Ventilation (PSV) or adjusting setting of VCV.

• Pain, anxiety and agitation will be treated by priority setting of the mechanical ventilator aimed to deliver the most comfortable ventilator support and secondly by adding analgesics and/or psychoactive drugs without inducing a coma state.- Persistent ventilator asynchrony or persistent agitation will be treated by 6-hours continuous sedation periods.

• Extubation will be performed according to criteria defined by the national consensus on mechanical ventilation weaning, which are based on a daily spontaneous breathing trial in the absence of any sedation.

Control group (standard practices):

• Continuous use of sedatives and analgesics (commonly called "sedation") will be daily stopped according to criteria defined by the national consensus on sedation for ICU patients.- During the period before the interruption of sedation, ventilator asynchrony in VCV will be treated by increasing the depth of sedation and then the dose of opioids.

• During the period before the interruption of sedation, pain, anxiety and agitation will be treated by a priority adjustment of sedation according to the nurse driven protocol recommended by the national consensus on sedation for ICU patients.- During the period after the interruption of sedation, ventilator asynchrony will be treated by switching to the PSV mode. In case of return to VCV, asynchrony will be treated by restart of sedation.

• During the period after the interruption of sedation, pain, anxiety and agitation will be treated as for the intervention group.

• Extubation will be performed according to criteria defined by the national consensus on mechanical ventilation weaning, which are based on a daily spontaneous breathing trial in the absence of any sedation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: S.O.S. Ventilation - Sedation Optimisation Strategy For Mechanical Ventilation In Intensive Care Unit Patients
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: S.O.S.-V	Other: Therapy strategy; Sedation & mechanical ventilation
No Intervention: Standard

Outcome Measures

Primary Outcome Measures

1. Time to successful intubation [for 48 hours after intubation]

   Time to successful intubation is defined as time from randomization to extubation (or tracheotomy mask) for 48 hours.

Secondary Outcome Measures

1. Dose and duration of sedation [Day 0 to Days 28]

   Dose and duration of sedation

2. Type and duration of mechanical ventilation [Day 0 to Days 28]

   Type and duration of mechanical ventilation

3. Complications acquired in ICU [Days 28]

   Complications acquired in ICU stress ulcers ileus infections delirium neuromuscular weakness pain

4. Length of stay in ICU and hospital [up to 6 months]

   Length of stay in ICU and hospital

5. Mortality [up to 12 months]

   ICU mortality, 3 months mortality and 12 months mortality

6. Quality of life, anxiety, depression, post-traumatic stress disorder 3 and 12 months after ICU discharge [up to 6 months]

   Quality of life, anxiety, depression, post-traumatic stress disorder 3 and 12 months after ICU discharge

7. Incidence and duration of organ dysfunctions [Day 1 to Days 5]

   Incidence and duration of organ dysfunctions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ventilated patient in assist control mode after a surgical procedure expected to be ventilated for 12-hours or more

• At least 1 organ dysfunction according to SOFA score

• Non paralyzed because of neuromuscular blocking agents

• Body temperature > or equal 36°CAge > or equal 18

• Surrogate decision maker's consent

Exclusion Criteria:

• Patients without any surgical procedure (medical patients)

• Continuous mechanical ventilation for 24-hours or longer

• Hospitalisation in ICU for 7-days or longer

• Severe ARDS (Acrasis study criteria, New England J Med 2011)

• Neurological injury

• Active toxicomania

• Reduction or cessation of active treatment

• Patient under tutelage

• Pregnancy

• No French health insurance

• Enrollment in another study on sedation or mechanical ventilation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology & Critical Care, Estaing University Hospital	Clermont-Ferrand		France	63000
2	Department of Anesthesiology & Critical Care, St Eloi University Hospital	Montpellier		France	34000
3	Department of Anesthesiology & Critical Care, Caremeau University Hospita	Nimes		France	30000

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

• Principal Investigator: Gerald GC Chanques, MD, PhD, UH, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT01486121
• Other Study ID Numbers: 8667
• First Posted: Dec 6, 2011
• Last Update Posted: Dec 2, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by University Hospital, Montpellier: Surgery; Critical illness; Mechanical ventilation; Organ dysfunction syndrome; Intensive Care Units Sedation; Analgesia; Treatment protocol; Nursing protocol; Outcome; Pain; Neurological disorders; Delirium; Muscular weakness; Psychological disorders; Anxiety; Depression; Stress disorders; Post-Traumatic
• Additional relevant MeSH terms: Syndrome; Critical Illness

Study Results

No Results Posted as of Dec 2, 2015