Characterization of Weaning Practices in ICUs of Global South Countries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Weaning From Mechanical Ventilation, Weaning Failure, Weaning From Mechanical Ventilation, Extubation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Characterization of Weaning Practices in ICUs of Global South Countries: A Prospective Observational Study
Overview
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).
Primary outcome measures
- Extubation failure within 7 days. [Time frame: 7 days.]
Secondary outcome measures (8)
- 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.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07337408 · GS Wean - Observational