NCT02911506

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

3.3 years

First QC Date

September 14, 2016

Last Update Submit

May 29, 2020

Conditions

Sleep QualityExtubation Failure

Outcome Measures

Primary Outcomes (1)

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

    24 hours

Interventions

PolysomnographyOTHER

Eligibility Criteria

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

Intensive care unit patients, intubated at least 24 hours, at risk of extubation failure

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Poitiers

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

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

Study Record Dates

First Submitted

September 14, 2016

First Posted

September 22, 2016

Study Start

November 1, 2015

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

June 1, 2020

Record last verified: 2020-05

Locations

FR(1)