NCT02920281

Brief Summary

The aim of the study is to evaluate the impact of sleep quality on the length of mechanical ventilation weaning, in intensive care unit patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

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, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

2.4 years

First QC Date

September 29, 2016

Last Update Submit

January 12, 2018

Conditions

Sleep QualityWeaning of Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • Compare the length of weaning patients who have a poor quality of sleep to those who have a good quality sleep.

    24 hours

Interventions

PolysomnographyOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mechanical ventilation for at least 24 hours before the first weaning test
  • difficult weaning of mechanical ventilation defined as failure to the first weaning test
  • patients aged at least of 18 years

You may not qualify if:

  • peripheral or central nervous system pathology
  • known psychiatric pathology or agitation
  • clinical worsening before polysomnography (shock with vasopressor drugs, coma with Glasgow scale \< 8, PaO2/FiO2 ratio \< 150 with respiratory distress signs)
  • pregnant or breastfeeding women
  • patient under legal guardianship or protection
  • patient with no health insurance coverage
  • age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Poitiers

Poitiers, 86000, France

Location

Related Publications (1)

  • Thille AW, Reynaud F, Marie D, Barrau S, Rousseau L, Rault C, Diaz V, Meurice JC, Coudroy R, Frat JP, Robert R, Drouot X. Impact of sleep alterations on weaning duration in mechanically ventilated patients: a prospective study. Eur Respir J. 2018 Apr 19;51(4):1702465. doi: 10.1183/13993003.02465-2017. Print 2018 Apr.

    PMID: 29519925DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2016

First Posted

September 30, 2016

Study Start

November 1, 2014

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

FR(1)