Characterization of Weaning Practices in ICUs of Global South Countries

NCT ID: NCT07337408

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital do Coracao

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Aline B Pereira

Role: CONTACT

linibp@hotmail.com

+55 (47) 99181-8400

Other Identifiers

GS Wean - Observational

Identifier Type: -

Identifier Source: org_study_id