Impact of Gamma-OH on sleep in ICU patients difficult to wean from mechanical ventilatio

Phase 1

• Conditions: Patients difficult to wean from mechanical ventilation in the ICU; MedDRA version: 21.1Level: PTClassification code 10067221Term: Mechanical ventilationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-002411-26-FR
• Lead Sponsor: CHU de Poitiers

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-30
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients intubated at least 24 hours in the intensive care unit and difficult to wean from mechanical ventilation according to international guidelines, i.e. who failed at least one spontaneous breathing trial.
Age = 18 years
Patients will be included after to obtain inform consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Patients with underlying neuromuscular disease (Myopathy or myasthenia gravis), or with central nervous disease (cancer, stroke, hemorrhage, Parkinson, seizures, multiple sclerosis….) or known psychiatric disease that may modify analysis of sleep recordings on polysomnography.
Patients with severe obesity (BMI 40 kg/m2) will be excluded to avoid under/overdose.
Contraindication to Gamma-OH®: hypersensitivity to the active substance or to any of the excipients, severe hypertension, bradycardia due to disorders of intracardiac conduction, uncorrected hypokalaemia, major depression, epilepsy, eclampsia, alcoholism, porphyria ,
Patients participating in another category 1 study, sleep assessment study, or study evaluating extubation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified