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NCT Number: NCT07337408

Characterization of Weaning Practices in ICUs of Global South Countries

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).

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Key information

Conditions

Weaning From Mechanical Ventilation Weaning Failure Weaning From Mechanical Ventilation, Extubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Extubation failure within 7 days.

    Time frame: 7 days.

    Defined as reintubation or death within 7 days after extubation.

Secondary outcomes

  1. Extubation within 28 days.

    Time frame: 28 days.

    Defined as extubation within 28 days after first separation attempt.

  2. Intensive care unit length of stay.

    Time frame: At intensive care unit discharge, up to 28 days.

    Defined as the number of days from the time of first separation attempt until discharge from the intensive care unit.

  3. Hospital length of stay.

    Time frame: At hospital discharge, up to 28 days.

    Defined as the number of days from the time of first separation attempt until discharge from the hospital.

  4. Reintubation or death within 28 days.

    Time frame: 28 days.

    Defined as composite criterion of reintubation or death within 28 days after first separation attempt.

  5. Intensive care unit mortality.

    Time frame: At intensive care unit discharge, up to 28 days.

    Defined as mortality from the time of first separation attempt until discharge from the intensive care unit.

  6. Hospital mortality.

    Time frame: At hospital discharge, up to 28 days.

    Defined as mortality from the time of first separation attempt until discharge from the hospital.

  7. Number of spontaneous breathing trials.

    Time frame: 28 days.

    Defined as the number of spontaneous breathing trials performed after first separation attempt.

  8. WIND classification.

    Time frame: 28 days.

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Aline B Pereira

CONTACT

[email protected]

+55 (47) 99181-8400

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Registry information

Official study title

Characterization of Weaning Practices in ICUs of Global South Countries: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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