Characterization of Weaning Practices in ICUs of Global South Countries

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Weaning Failure; Weaning From Mechanical Ventilation; Weaning From Mechanical Ventilation, Extubation

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Aline B Pereira; Phone Number: +55 (47) 99181-8400; Email: linibp@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Lack of informed consent.
• Terminal extubation.
• Previously included in the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation failure within 7 days.	Defined as reintubation or death within 7 days after extubation.	7 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation within 28 days.	Defined as extubation within 28 days after first separation attempt.	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.	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.	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.	28 days.
Intensive care unit mortality.	Defined as mortality from the time of first separation attempt until discharge from the intensive care unit.	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.	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.	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).	28 days.

Collaborators and Investigators

• Sponsor: Hospital do Coracao

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Weaning from mechanical ventilation; Weaning Failure; Weaning from mechanical ventilation, extubation
• Other Study ID Numbers: GS Wean - Observational

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No