NCT05550259

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

September 19, 2022

Last Update Submit

September 30, 2022

Conditions

Extubation Failure

Outcome Measures

Primary Outcomes (1)

  • Rate of reintubation

    Reintubation following extubation

    7 days following extubation

Study Arms (2)

control period

NO INTERVENTION

the control period corresponds to usual care of centers

protocolized period

EXPERIMENTAL

the protocolized period corresponds to a protocolized use of HFNO or NIV after extubation

Procedure: protocolized postextubation support

Interventions

protocolized postextubation supportPROCEDURE

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

protocolized period

Eligibility Criteria

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

You may qualify if:

  • Adult patients
  • Intubated more than 24 hours in the ICU
  • Ready for a scheduled extubation then extubated

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: A stepped wedge cluster randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 22, 2022

Study Start

October 1, 2022

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

October 3, 2022

Record last verified: 2022-09