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

This study is currently recruiting participants.
Verified September 2016 by Poitiers University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907008
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Poitiers University Hospital
  Purpose
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

Condition Intervention
Sleep Quality Hypoxemic Acute Respiratory Failure Intubation Risk Other: Polysomnography

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Sleep Quality and Risk of Intubation in Intensive Care Units Patients With Hypoxemic Acute Respiratory Failure

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:
  • 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 [ Time Frame: 24h ]

Estimated Enrollment: 35
Study Start Date: December 2015
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
intensive care units patients with hypoxemic acute respiratory failure
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907008


Contacts
Contact: Arnaud W THILLE, PHD arnaud.thille@chu-poitiers.fr
Contact: Damien MARIE, Intern damien.marie01@gmail.com

Locations
France
Chu Poitiers Recruiting
Poitiers, France, 86000
Contact: Arnaud W THILLE, PHD       arnaud.thille@chu-poitiers.fr   
Sponsors and Collaborators
Poitiers University Hospital
  More Information

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT02907008     History of Changes
Other Study ID Numbers: HIGH SLEEP
First Submitted: September 15, 2016
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases