NCT05801692

Brief Summary

Weaning of mechanical ventilation is an important phase of ICU (Intensive Care Unit) patient hospitalization. Patients have to pass a spontaneous breathing trial, can have a phase of pause with mechanical ventilation before extubation and then can be weaned of invasive mechanical ventilation. Spontaneous breathing trial can be performed with a T-Tube or with Pressure support without PEEP (End Expiratory Positive Pressure) . Duration of spontaneous breathing trial range from 30 minutes to 120 minutes. Some clinicians performed an arterial blood gases at the end of the spontaneous breathing trial but this practice is not really defined and clearly explained in recommendations. Patients can benefit of ventilation support after extubation like non invasive pressure support or high flow nasal canulae. The procedure can be very different from a center to another, especially for arterial blood gases at the end of spontaneous breathing trial. Our aim is to observe in a multicenter study the daily practice of weaning of mechanical ventilation especially for arterial blood gases.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 21, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

April 6, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

February 10, 2023

Last Update Submit

March 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Type of spontaneous breathing trial performed

    Spontaneous breathing trial is performed either with pressure support or with a T-Piece

    In the 24 hours of spontaneous breathing trial

Secondary Outcomes (9)

  • Arterial blood gases at the end of spontaneous breathing trial

    In the hour of spontaneous breathing trial

  • Duration of spontaneous breathing trial

    The day of the spontaneous breathing trial

  • Ventilatory procedure at the end of spontaneous breathing trial: either immediate extubation or pressure support ventilation with intubation

    The day of extubation if extubation performed

  • Frequency and type of ventilatory support after extubation

    The day of extubation if extubation performed

  • Need for reintubation

    During the seven days following extubation

  • +4 more secondary outcomes

Interventions

Weaning of mechanical ventilation is the time when the patient is ready for separation from ventilatory support until breathing without invasive support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in intensive care unit with invasive mechanical ventilation, first attempt of weaning of mechnical ventilation

You may qualify if:

  • Older than 18 years
  • first attempt of weaning of mechanical ventilation

You may not qualify if:

  • withholding of life sustaining therapies
  • spontaneous breathing trial unsuccessful

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BARROT

Besançon, 25320, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2023

First Posted

April 6, 2023

Study Start

December 21, 2022

Primary Completion

July 1, 2023

Study Completion

October 1, 2023

Last Updated

April 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations