Patients difficult to wean from mechanical ventilation in the ICU MedDRA version: 21.1 Level: PT Classification code 10067221 Term: Mechanical ventilation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Gamma-OH®
Product Name: GAMMA-OH
Product Code: GAMMA-OH
Pharmaceutical Form: Solution for injection
Sponsors
CHU de Poitiers
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess sleep quality with Gamma-OH® in patients difficult to wean from mechanical ventilation in the ICU;Secondary Objective: To assess with Gamma-OH® the proportion of patients with atypical sleep, without REM (rapid eye movment), without deep sleep, duration of sleep during polysomnography, duration of different sleep stages (in minute and %), the number of arousals and awakening per hour (fragmentation of sleep), and time to extubation. All adverse events will be collected during the study period. ;Primary end point(s): Proportion of patients having poor sleep with Gamma-OH®, defined as one of the following criterion: no sleep REM, no deep sleep, or atypical sleep.;Timepoint(s) of evaluation of this end point: During a single night with Gamma-OH®. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients with atypical sleep, presence of REM sleep, deep sleep, total duration of sleep during polysomnography, duration of different sleep stages, number of arousals and awakenings per hour of sleep, time to extubation in days, and potential adverse events induced by Gamma-OH®;Timepoint(s) of evaluation of this end point: During a single night with Gamma-OH®, and then until extubation (weaning duration). | — |
Countries
France
Contacts
Public ContactFanny ABRIAT
CHU de Poitiers
Outcome results
None listed