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
- Are there results?
- Not yet: the study is under way
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.
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Weaning Practices in ICUs of Global South Countries: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07337408
- Acronym / sponsor ID
- GS Wean - Observational
- Conditions
- Weaning From Mechanical Ventilation, Weaning Failure, Weaning From Mechanical Ventilation, Extubation
- Keywords
- Weaning from mechanical ventilation, Weaning Failure, Weaning from mechanical ventilation, extubation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- 25 May 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extubation failure within 7 days.
Time frame: 7 days.
Defined as reintubation or death within 7 days after extubation.
8 secondary outcomes
Extubation within 28 days.
Time frame: 28 days.
Intensive care unit length of stay.
Time frame: At intensive care unit discharge, up to 28 days.
Hospital length of stay.
Time frame: At hospital discharge, up to 28 days.
Reintubation or death within 28 days.
Time frame: 28 days.
Intensive care unit mortality.
Time frame: At intensive care unit discharge, up to 28 days.
Hospital mortality.
Time frame: At hospital discharge, up to 28 days.
Number of spontaneous breathing trials.
Time frame: 28 days.
WIND classification.
Time frame: 28 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning From Mechanical Ventilation and Weaning Failure, run by Hospital do Coracao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aline B Pereira (+55 (47) 99181-8400, linibp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation failure within 7 days. (time frame: 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.