Sleep Quality in Intensive Care Unit Patients at High Risk of Extubation Failure

Sleep Quality Clinical Trial

— WEAN SLEEP 2  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911506
• Other study ID #: WEAN SLEEP 2
• Status: Completed
• Start date: November 2015
• Est. completion date: March 2019

Study information

• Verified date: May 2020
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to evaluate the impact of sleep quality on extubation failure rate in intensive care unit patients at high risk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Intensive care units patients intubated for at least 24 hours with at least on of the four following risk factor : aged of 65 years or more, any underlying chronic cardiac or lung disease, mechanical ventilation for more than 7 days.

• aged of 18 years or more

Exclusion Criteria:

• peripheral or central nervous system pathology

• known psychiatric pathology or agitation

• patient with decision of no reintubation

• patient refusal

• clinical worsening before polysomnography ( shock with vasopressors drugs, coma, PaO2/FiO2 ratio < 150 with respiratory distress signs, coma with Glasgow scale <8)

• pregnant or breastfeeding women

• patient under legal guardianship or protection

• patient with no health insurance coverage

• aged < 18 years

Related Conditions & MeSH terms

• Extubation Failure
• Sleep Quality

Intervention

Other:
• Polysomnography

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	Evaluation of sleep quality by polysomnography recording on the extubation day.		24 hours