Characterization of Weaning Practices in ICUs of Global South Countries

NCT07337408 | Recruiting

• 1 other identifier: GS Wean - Observational
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Extubation failure within 7 days.

  Defined as reintubation or death within 7 days after extubation.

  7 days.

Secondary Outcomes (8)

• Extubation within 28 days.

  28 days.

• Intensive care unit length of stay.

  At intensive care unit discharge, up to 28 days.

• Hospital length of stay.

  At hospital discharge, up to 28 days.

• Reintubation or death within 28 days.

  28 days.

• Intensive care unit mortality.

  At intensive care unit discharge, up to 28 days.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital do Coracao: lead

Study Sites (1)

Centro Hospitalar Unimed Joinville

Joinville, Santa Catarina, Brazil

RECRUITING

Central Study Contacts

Aline B Pereira

CONTACT

+55 (47) 99181-8400; linibp@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 13, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

BR (1)