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

Acute Respiratory Failure Requiring Reintubation Clinical Trial

— HIGH-WEAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03121482
• Other study ID #: HIGH-WEAN Study
• Secondary ID: 2016-A01078-43
• Status: Completed
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: April 17, 2018

Study information

• Verified date: March 2019
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: April 17, 2018
• Est. primary completion date: April 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure Requiring Reintubation
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• HFNC
Gas flow of 50 l/min and FiO2 adjusted to obtain SpO2 = 92%
• NIV
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%

Locations

Country	Name	City	State
France	CHU Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reintubation at Day 7	The rate of reintubation will be assessed within the 7 days following planned extubation	up to 7 days