Skip to main content
OpenTrials
Completed

NCT Number: NCT01486121

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgery Agnosia Anxiety Disorders Behavior Behavioral Symptoms Confusion Critical Illness Delirium Depression Disease Attributes Intensive Care Unit Syndrome Mechanical Ventilation Complication Mental Disorders Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Neuromuscular Manifestations Organ Dysfunction Syndrome Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Anesthesiology & Critical Care, Estaing University Hospital, Clermont-Ferrand, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapy strategy

Other

Sedation & mechanical ventilation

Primary outcomes

  1. Time to successful intubation

    Time frame: for 48 hours after intubation

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

Secondary outcomes

  1. Dose and duration of sedation

    Time frame: Day 0 to Days 28

    Dose and duration of sedation

  2. Type and duration of mechanical ventilation

    Time frame: Day 0 to Days 28

    Type and duration of mechanical ventilation

  3. Complications acquired in ICU

    Time frame: Days 28

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

  4. Length of stay in ICU and hospital

    Time frame: up to 6 months

    Length of stay in ICU and hospital

  5. Mortality

    Time frame: 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

    Time frame: 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

    Time frame: Day 1 to Days 5

    Incidence and duration of organ dysfunctions

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 6, 2011
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.