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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04224246
Other study ID # GO-SLEEP
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date January 2020
Est. completion date December 1, 2021

Study information

Verified date January 2020
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date December 1, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Weaning From Mechanical Ventilation

Intervention

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

Locations

Country Name City State
France CHU Poitiers Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients having poor sleep with Gamma-OH Primary end point will be analyzed from sleep recordings performed during a single night with Gamma-OH®. Hour24
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