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OpenTrials
Completed

NCT Number: NCT02911506

Sleep Quality in Intensive Care Unit Patients at High Risk of Extubation Failure

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Poitiers

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Polysomnography

Other

Primary outcomes

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

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: WEAN SLEEP 2

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 22, 2016
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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