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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486121
• Other study ID #: 8667
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2011
• Last updated: December 1, 2015
• Start date: December 2011
• Est. completion date: April 2015

Study information

• Verified date: December 2015
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Other:
• Therapy strategy
Sedation & mechanical ventilation

Locations

Country	Name	City	State
France	Department of Anesthesiology & Critical Care, Estaing University Hospital	Clermont-Ferrand
France	Department of Anesthesiology & Critical Care, St Eloi University Hospital	Montpellier
France	Department of Anesthesiology & Critical Care, Caremeau University Hospita	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Dose and duration of sedation	Dose and duration of sedation	Day 0 to Days 28	No
Secondary	Type and duration of mechanical ventilation	Type and duration of mechanical ventilation	Day 0 to Days 28	No
Secondary	Complications acquired in ICU	Complications acquired in ICU stress ulcers ileus infections delirium neuromuscular weakness pain	Days 28	No
Secondary	Length of stay in ICU and hospital	Length of stay in ICU and hospital	up to 6 months	No
Secondary	Mortality	ICU mortality, 3 months mortality and 12 months mortality	up to 12 months	No
Secondary	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	No
Secondary	Incidence and duration of organ dysfunctions	Incidence and duration of organ dysfunctions	Day 1 to Days 5	No