Impact of Gamma-OH on Sleep in ICU Patients

Overview

The Main objective of the trial is to assess sleep quality with Gamma-OH® in patients difficult to wean from mechanical ventilation in the ICU.

Full Title of Study: “Impact of Gamma-OH on Sleep in ICU Patients Difficult to Wean From Mechanical Ventilation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2021

Interventions

  • Drug: Gamma Hydroxybutyrate
    • Gamma-OH® will be administered intravenously at a dose of 20 mg/kg/h for 6 hours

Arms, Groups and Cohorts

  • Experimental: One arm with Gamma-OH® treatment
    • Gamma-OH® will be administered intravenously at a dose of 20 mg/kg/h for 6 hours between 10 p.m. to 4 a.m.

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of patients having poor sleep with Gamma-OH
    • Time Frame: Hour24
    • Primary end point will be analyzed from sleep recordings performed during a single night with Gamma-OH®.

Participating in This Clinical Trial

Inclusion Criteria

  • intubated at least 24 hours – difficult weaning from mechanical ventilation according to international guidelines, i.e. who failed at least one spontaneous breathing trial. – Patients will be included after to obtain inform consent. Exclusion Criteria:

  • neuromuscular disease – central nervous disease – psychiatric disease – severe obesity

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Poitiers University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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