Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT06133504
Eligibility Criteria:
Inclusion Criteria:
The inclusion criteria are as follows:
Patients hospitalized in the adult intensive care unit of the Fundación Santa Fe de Bogotá.
Requirement of invasive mechanical ventilation through an endotracheal tube for a period exceeding 72 hours with an expected continuation of at least 24 hours.
Barthel Index equal to or greater than 70
Exclusion Criteria:
* Invasive mechanical ventilation through tracheostomy or a nasotracheal tube.
* History of head and neck surgery at any time prior to ICU admission.
* Patients directly admitted to the ICU due to cardiac arrest by any cause.
* Airway burn.
* Burns involving ≥ 50% of the body surface area.
* Chronic obstructive pulmonary disease (these patients usually require prolonged mechanical ventilation due to the underlying respiratory dysfunction)
* Patients referred from another institution.
* Demyelinating diseases or neuromuscular junction disorders at ICU admission.
* Patients requiring neuromuscular blockade.
* Patients with a life expectancy of ≤180 days will be excluded based on their primary diagnosis (e.g., advanced cancer, end-stage heart failure), comorbidities, recent clinical course, medical judgment by the ICU team, and functional status as assessed by the Barthel index.
* ICU readmissions.
* Participation in other rehabilitation clinical trials.
* Liver or kidney transplant.
* Patients with an active cancer diagnosis undergoing oncological treatment (chemotherapy/surgery) at the time of eligibil- ity assessment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06133504
Study Brief:
Protocol Section:
NCT06133504