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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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S.O.S. Ventilation - Sedation Optimisation Strategy For Mechanical Ventilation In Intensive Care Unit Patients

Conditions
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Surgery, Critical Illness, Mechanical Ventilation Complication, Organ Dysfunction Syndrome, Intensive Care Unit Syndrome

Intervention / Treatment
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* Other: Therapy strategy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: S.O.S.-V<br> | Other: Therapy strategy<br>* Sedation & mechanical ventilation<br>|
| No Intervention: Standard<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to successful intubation | Time to successful intubation is defined as time from randomization to extubation (or tracheotomy mask) for 48 hours. | for 48 hours after intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose and duration of sedation | Dose and duration of sedation | Day 0 to Days 28 | 
| Type and duration of mechanical ventilation | Type and duration of mechanical ventilation | Day 0 to Days 28 | 
| Complications acquired in ICU | Complications acquired in ICU stress ulcers ileus infections delirium neuromuscular weakness pain | Days 28 | 
| Length of stay in ICU and hospital | Length of stay in ICU and hospital | up to 6 months | 
| Mortality | ICU mortality, 3 months mortality and 12 months mortality | up to 12 months | 
| Quality of life, anxiety, depression, post-traumatic stress disorder 3 and 12 months after ICU discharge | Quality of life, anxiety, depression, post-traumatic stress disorder 3 and 12 months after ICU discharge | up to 6 months | 
| Incidence and duration of organ dysfunctions | Incidence and duration of organ dysfunctions | Day 1 to Days 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical ventilation, Surgery, Critical illness, 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