E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients difficult to wean from mechanical ventilation in the ICU |
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E.1.1.1 | Medical condition in easily understood language |
Patients difficult to wean from mechanical ventilation in the ICU |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067221 |
E.1.2 | Term | Mechanical ventilation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess sleep quality with Gamma-OH® in patients difficult to wean from mechanical ventilation in the ICU |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During a single night with Gamma-OH®. |
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E.5.2 | 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® |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During a single night with Gamma-OH®, and then until extubation (weaning duration). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
mais ne recevant pas de Gamma-OH® |
Patients in our previous study who had exactly the same inclusion criteria and the same conditions |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |