Status:
COMPLETED
Sedation Optimisation Strategy (S.O.S.) Ventilation
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Surgery
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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) wil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01486121
Start Date
December 1 2011
End Date
April 1 2015
Last Update
December 2 2015
Active Locations (3)
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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
Nîmes, France, 30000