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

NCT01486121 | Completed Phase 3

• 1 other identifier: 8667
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Dose and duration of sedation

  Day 0 to Days 28

• Type and duration of mechanical ventilation

  Day 0 to Days 28

• Complications acquired in ICU

  Days 28

• Length of stay in ICU and hospital

  up to 6 months

• Mortality

  up to 12 months

Study Arms (2)

S.O.S.-V

OTHER

Other: Therapy strategy

Standard

NO INTERVENTION

Interventions

Therapy strategy OTHER

Sedation \& mechanical ventilation

S.O.S.-V

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (3)

Department of Anesthesiology & Critical Care, Estaing University Hospital

Clermont-Ferrand, 63000, France

Location

Department of Anesthesiology & Critical Care, St Eloi University Hospital

Montpellier, 34000, France

Location

Department of Anesthesiology & Critical Care, Caremeau University Hospita

Nîmes, 30000, France

Location

Related Publications (1)

• 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.

  PMID: 28935558 DERIVED

MeSH Terms

Conditions

Critical Illness; Agnosia; Pain; Nervous System Diseases; Delirium; Muscle Weakness; Mental Disorders; Anxiety Disorders; Depression; Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Confusion; Neurocognitive Disorders; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Behavioral Symptoms; Behavior; Trauma and Stressor Related Disorders

Study Officials

• Gerald GC Chanques, MD, PhD

  UH, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: December 6, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-12

Locations

FR (3)