Clinical trial NCT01486121: Sedation Optimisation Strategy (S.O.S.) Ventilation
Official title: S.O.S. Ventilation - Sedation Optimisation Strategy For Mechanical Ventilation In Intensive Care Unit Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgery
Critical Illness
Mechanical Ventilation Complication
Organ Dysfunction Syndrome
Intensive Care Unit Syndrome
Keywords: 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
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to successful intubation
timeFrame: for 48 hours after intubation
Secondary outcomes:
measure: Dose and duration of sedation
timeFrame: Day 0 to Days 28
measure: Type and duration of mechanical ventilation
timeFrame: Day 0 to Days 28
measure: Complications acquired in ICU
timeFrame: Days 28
measure: Length of stay in ICU and hospital
timeFrame: up to 6 months
measure: Mortality
timeFrame: up to 12 months
measure: Quality of life, anxiety, depression, post-traumatic stress disorder 3 and 12 months after ICU discharge
timeFrame: up to 6 months
measure: Incidence and duration of organ dysfunctions
timeFrame: Day 1 to Days 5
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Department of Anesthesiology & Critical Care, Estaing University Hospital
city: Montpellier
country: France
facility: Department of Anesthesiology & Critical Care, St Eloi University Hospital
city: Nimes
country: France
facility: Department of Anesthesiology & Critical Care, Caremeau University Hospita
Study officials:
affiliation: UH, Montpellier
name: Gerald GC Chanques, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chanques G, Conseil M, Roger C, Constantin JM, Prades A, Carr J, Muller L, Jung B, Belafia F, Cisse M, Delay JM, de Jong A, Lefrant JY, Futier E, Mercier G, Molinari N, Jaber S; SOS-Ventilation study investigators. Immediate interruption of sedation compared with usual sedation care in critically ill postoperative patients (SOS-Ventilation): a randomised, parallel-group clinical trial. Lancet Respir Med. 2017 Oct;5(10):795-805. doi: 10.1016/S2213-2600(17)30304-1. Epub 2017 Sep 18.