Weaning From Mechanical VentilationNCT07337408
Characterization of Weaning Practices in ICUs of Global South Countries
An observational study of Weaning From Mechanical Ventilation and Weaning Failure, run by Hospital do Coracao at 1 site in Brazil.
Trial summary
This is a prospective observational study to be conducted in intensive care units of Global South countries. Patients on mechanical ventilation for more than 12 hours who have initiated the weaning process and for whom the attending team plans extubation within the next 6 hours will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning From Mechanical Ventilation, Weaning Failure, Weaning From Mechanical Ventilation, Extubation
- How many people
- 900 participants
- Where
- 1 siteBrazil
- Study dates
- 25 May 2026to Apr 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving mechanical ventilation for more than 12 hours who are planning to undergo the first separation attempt from the invasive mechanical ventilation (as defined in the WIND Classification) in the next 6 hours or that has undergone a separation attempt less than 2 hours ago will be included.
Who may be able to join
- Age > 18 years.
- Receiving care at an intensive care unit.
- Endotracheal intubation.
- Mechanical ventilation for 12 hours or more.
- First separation attempt, as defined in the WIND Classification - "Separation attempt from mechanical ventilation: an spontaneous breathing trial with or without extubation, or an extubation directly performed without identified spontaneous breathing trial (whatever the type: planned or unplanned extubation)" - planned to occur in the next 6 hours or that occurred less than 2 hours ago.
Who cannot join
- Patients with prior extubation failure.
- Patients with prior spontaneous breathing trial failure.
- Patients unable to obey commands.
- Neuromuscular disease or cervical spinal cord injury.
- Tracheostomy.
- Do-not-resuscitate order or contraindication for reintubation.
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- Lack of informed consent.
- Terminal extubation.
- Previously included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Centro Hospitalar Unimed Joinville
Joinville, Santa Catarina
Braz Pereira, 55 47 99181-8400, linibp@hotmail.com
About this study
Official title: Characterization of Weaning Practices in ICUs of Global South Countries: A Prospective Observational Study
This is a prospective observational study to be conducted in intensive care units of Global South countries. Patients on mechanical ventilation for more than 12 hours who have initiated the weaning process and for whom the attending team plans extubation within the next 6 hours will be included. Data will be collected for each patient during the first 7 days after extubation, with follow-up until hospital discharge or death. We plan to conduct the study in intensive care units from Global South countries (low- and middle-income countries predominantly located in the Southern Hemisphere, though some in the Northern Hemisphere are also considered).
- Conditions
- Weaning From Mechanical Ventilation, Weaning Failure, Weaning From Mechanical Ventilation, Extubation
- Keywords
- Weaning from mechanical ventilation, Weaning Failure, Weaning from mechanical ventilation, extubation
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation failure within 7 days.
Defined as reintubation or death within 7 days after extubation.
Measured: 7 days.
Secondary outcomes (8)
Extubation within 28 days.
Defined as extubation within 28 days after first separation attempt.
Measured: 28 days.
Intensive care unit length of stay.
Defined as the number of days from the time of first separation attempt until discharge from the intensive care unit.
Measured: At intensive care unit discharge, up to 28 days.
Hospital length of stay.
Defined as the number of days from the time of first separation attempt until discharge from the hospital.
Measured: At hospital discharge, up to 28 days.
Reintubation or death within 28 days.
Defined as composite criterion of reintubation or death within 28 days after first separation attempt.
Measured: 28 days.
Intensive care unit mortality.
Defined as mortality from the time of first separation attempt until discharge from the intensive care unit.
Measured: At intensive care unit discharge, up to 28 days.
Hospital mortality.
Defined as mortality from the time of first separation attempt until discharge from the hospital.
Measured: At hospital discharge, up to 28 days.
Number of spontaneous breathing trials.
Defined as the number of spontaneous breathing trials performed after first separation attempt.
Measured: 28 days.
WIND classification.
Group 1 (short weaning): the first separation attempt resulted in a termination of the weaning process within 24 hours (successful separation or early death). • Group 2 (difficult weaning): weaning was terminated after more than 1 day but in less than 1 week after the first separation attempt (successful separation or death). • Group 3 (prolonged weaning): weaning was still not terminated 7 days after the first separation attempt (by success or death).
Measured: 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start25 May 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning From Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337408
- Sponsor's protocol ID
- GS Wean - Observational
- Status last verified
- Sep 2026
- First submitted
- 23 Dec 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No