Clinical Trials Logo
  1. Home
  2. Extubation Failure
  3. NCT05550259
  4. Details
NCT05550259 Clinical Trial

Ventilation Support for the PREvenTion of EXTubation Failure

Extubation Failure Clinical Trial

— PRETEEXT  

Official title:
Evaluation of an Oxygenation and Ventilation Support Protocol for the PREvenTion of EXTubation Failure: a Stepped Wedge Cluster Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05550259
Other study ID # 3480
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2022
Est. completion date February 2024

Study information
Verified date September 2022
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Reintubation after failed extubation would be associated with increased mortality. Therefore, extubation failure remains a major concern in ICU. Few randomized controlled studies have assessed the benefit for a systematic respiratory support (noninvasive ventilation or high flow nasal cannula) applied at the time of extubation to reduce reintubation rates in patients at high and low risk for reintubation. In addition, these studies reported discordant results. Therefore, there are some concerns regarding effectiveness and systematic uptake of a respiratory support after extubation into usual practice.

Description:

The aim of this trial is to determine whether a protocolized postextubation respiratory support including High-flow Nasal Oxygen (HFNO) and Noninvasive Ventilation (NIV) could reduce the rate of reintubation in comparison with usual practice. Therefore, all consecutively eligible patients for the study, will be assigned to a protocol arm in accordance with the randomized period

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1100
Est. completion date February 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients - Intubated more than 24 hours in the ICU - Ready for a scheduled extubation then extubated Exclusion Criteria: - Contraindication to HFNO or NIV - Underlying chronic neuromuscular disease - Unplanned extubation (accidental or self-extubation) - With a do-not-reintubate order at time of extubation - Tracheotomia

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• protocolized postextubation support
The intervention corresponds to a protocolized use of HFNO or NIV after extubation in accordance with the risk of extubation failure: a) 24H HFNO in patient at low risk of extubation failure b) 48H NIV+/-HFNO in patients at high risk of extubation failure

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of reintubation Reintubation following extubation 7 days following extubation
See also
  Status Clinical Trial Phase
Completed NCT00979433 - Bubble Continuous Positive Airway Pressure (CPAP) With Conventional CPAP for Extubation in Preterm Infants N/A
Not yet recruiting NCT05487573 - Performance of the Variation in Arterial Lactatemia During a Spontaneous Breathing Trial (SBT) in the Prediction of Extubation Failure
Completed NCT03361683 - Post-extubation High-flow Nasal Oxygen for Preventing Extubation Failure N/A
Completed NCT02911506 - Sleep Quality in Intensive Care Unit Patients at High Risk of Extubation Failure
Recruiting NCT05944588 - Predictive Value of Chest Ultrasound Observation on Extubation Failure
Recruiting NCT00977002 - Prevention of Reintubation by Using Noninvasive Positive Pressure Ventilation Phase 3
Completed NCT04125342 - Postextubation High-flow Therapy vs Noninvasive Ventilation in Obese or at High-risk Patients N/A
Recruiting NCT05918575 - Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients N/A
Recruiting NCT04010617 - PES to Avoid Extubation Failure in Intubated Stroke Patients at High Risk of Severe Dysphagia N/A
Recruiting NCT05446272 - The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial N/A
Not yet recruiting NCT02887846 - Comparing HHHFNC and nCPAP Ventilation Methods for the Prevention of Extubation Failure in Preterm Infants Phase 4
Recruiting NCT05637099 - The Value of Repeated BIOMarker Measurements During an SBT to Predict EXtubation Failure in ICU Patients
Recruiting NCT05081973 - A Model for Predicting Extubation Success in Premature Babies