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

This study is currently recruiting participants.
Verified April 2013 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01486121
First received: November 10, 2011
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Surgery
Critical Illness
Mechanical Ventilation Complication
Organ Dysfunction Syndrome
Intensive Care Unit Syndrome
Other: Therapy strategy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: S.O.S. Ventilation - Sedation Optimisation Strategy For Mechanical Ventilation In Intensive Care Unit Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Time to successful intubation [ Time Frame: for 48 hours after intubation ] [ Designated as safety issue: No ]
    Time to successful intubation is defined as time from randomization to extubation (or tracheotomy mask) for 48 hours.


Secondary Outcome Measures:
  • Dose and duration of sedation [ Time Frame: Day 0 to Days 28 ] [ Designated as safety issue: No ]
    Dose and duration of sedation

  • Type and duration of mechanical ventilation [ Time Frame: Day 0 to Days 28 ] [ Designated as safety issue: No ]
    Type and duration of mechanical ventilation

  • Complications acquired in ICU [ Time Frame: Days 28 ] [ Designated as safety issue: No ]
    Complications acquired in ICU stress ulcers ileus infections delirium neuromuscular weakness pain

  • Length of stay in ICU and hospital [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Length of stay in ICU and hospital

  • Mortality [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    ICU mortality, 3 months mortality and 12 months mortality

  • Quality of life, anxiety, depression, post-traumatic stress disorder 3 and 12 months after ICU discharge [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Quality of life, anxiety, depression, post-traumatic stress disorder 3 and 12 months after ICU discharge

  • Incidence and duration of organ dysfunctions [ Time Frame: Day 1 to Days 5 ] [ Designated as safety issue: No ]
    Incidence and duration of organ dysfunctions


Estimated Enrollment: 140
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
S.O.S.-V Other: Therapy strategy
Sedation & mechanical ventilation
No Intervention: Standard

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486121

Contacts
Contact: Gerald GC Chanques, MD, PhD +33467337572 g-chanques@chu-montpellier.fr

Locations
France
Department of Anesthesiology & Critical Care, Estaing University Hospital Not yet recruiting
Clermont-Ferrand, France, 63000
Contact: Jean-Michel JMC Constantin, PU-PH    +33473750501    jmconstantin@chu-clermontferrand.fr   
Department of Anesthesiology & Critical Care, St Eloi University Hospital Recruiting
Montpellier, France, 34000
Contact: Gerald GC Chanques, MD, PhD    +33467337572    g-chanques@chu-montpellier.fr   
Department of Anesthesiology & Critical Care, Caremeau University Hospita Not yet recruiting
Nimes, France, 30000
Contact: Jean-Yves JYL Lefrant, PU-PH    +33466683050    jean.yves.lefrant@chu-nimes.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Gerald GC Chanques, MD, PhD UH, Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01486121     History of Changes
Other Study ID Numbers: UF 8667
Study First Received: November 10, 2011
Last Updated: April 15, 2013
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by University Hospital, Montpellier:
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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014