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NCT02907008 Clinical Trial

Sleep Quality and Risk of Intubation in Intensive Care Units Patients With Hypoxemic Acute Respiratory Failure

Sleep Quality Clinical Trial

— HIGH SLEEP  

Official title:
Sleep Quality and Risk of Intubation in Intensive Care Units Patients With Hypoxemic Acute Respiratory Failure

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02907008
Other study ID # HIGH SLEEP
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2015
Est. completion date May 2020

Study information
Verified date February 2019
Source Poitiers University Hospital
Contact Arnaud W THILLE, PHD
Email arnaud.thille@chu-poitiers.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to evaluate the impact of sleep quality on intubation rate in intensive care units patients with acute respiratory failure

Recruitment information / eligibility
Status Recruiting
Enrollment 35
Est. completion date May 2020
Est. primary completion date November 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Acute respiratory failure

- hypoxemia with PaO2/FiO2 ratio < 300 mmHg

- aged of 18 years or more

Exclusion Criteria:

- Need of immediate intubation

- Need of vasopressor drugs

- coma with Glasgow scale < 8

- Acute respiratory failure linked to cardiogenic pulmonary oedema

- Chronic respiratory insufficiency

- Peripheral or central nervous system pathology

- Known psychiatric pathology or agitation

- Patient with decision of no intubation

- Patient refusal

- Pregnant or breastfeeding women

- Patient under legal guardianship or protection

- Patients with no health insurance coverage

Study Design

Related Conditions & MeSH terms

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 to compare the intubation rate of patients with hypoxemic acute respiratory failure between those who have a poor quality of sleep and those who have a good quality of sleep 24h
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