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Completed

NCT Number: NCT03121482

High-flow Nasal Cannula Oxygen Therapy With or Without NIV During the Weaning Period

Prospective multicenter randomized controlled open-label trial comparing 2 strategies of oxygenation during the post-extubation period in ICU patients at high risk of extubation failure. Patients will be randomized and assigned to one of the two groups, with a 1:1 ratio.

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Key information

Conditions

Acute Respiratory Failure Requiring Reintubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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

  • Duration of mechanical ventilation prior to extubation at least 24h
  • Planned extubation decided by the physician in charge of the patient after success of a weaning trial
  • Patients at high risk of reintubation according to the following criteria: patients older than 65 years, or those having any underlying chronic cardiac or lung disease.

Exclusion criteria

  • Patient admitted for traumatic brain injury
  • Periphal neuromuscular disease as reason for intubation
  • Usual lon-term treatment with NIV for chronic desease
  • Usual lon-term treatment with CPAP for obstructive apneas syndrome
  • Contraindication to NIV
  • Unplanned extubation
  • Do-not-reintubated order at time of extubation
  • Terminal extubation for end of life
  • People under legal protection
  • Opposition to participate

Treatment and study plan

HFNC

Device

Gas flow of 50 l/min and FiO2 adjusted to obtain SpO2 ≥ 92%

NIV

Device

Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cm H2O with FiO2 adjusted to obtain SpO2 ≥ 92%

Primary outcomes

  1. Reintubation at Day 7

    Time frame: up to 7 days

    The rate of reintubation will be assessed within the 7 days following planned extubation

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

High-flow Nasal Cannula Oxygen Therapy With or Without Non-invasive Ventilation (NIV) During the Weaning Period: a Multicenter Randomized Controlled Trial

Acronym: HIGH-WEAN

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2017
Registry last updated
Mar 13, 2019

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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