NCT02907008

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

3.9 years

First QC Date

September 15, 2016

Last Update Submit

February 21, 2019

Conditions

Sleep QualityHypoxemic Acute Respiratory FailureIntubation Risk

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

PolysomnographyOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

intensive care units patients with hypoxemic acute respiratory failure

You may qualify if:

  • Acute respiratory failure
  • hypoxemia with PaO2/FiO2 ratio \< 300 mmHg
  • aged of 18 years or more

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Poitiers

Poitiers, 86000, France

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersRespiration DisordersRespiratory Tract Diseases

Central Study Contacts

Arnaud W THILLE, PHD

CONTACT

arnaud.thille@chu-poitiers.fr

Damien MARIE, Intern

CONTACT

damien.marie01@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2016

First Posted

September 20, 2016

Study Start

December 1, 2015

Primary Completion

November 1, 2019

Study Completion

May 1, 2020

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations

FR(1)