Status:
NOT_YET_RECRUITING
Early Multimodal Therapy and Mechanical Ventilation
Lead Sponsor:
Fundación Santa Fe de Bogota
Conditions:
Critical Care
Critical Illness
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
To assess the association between early multimodal therapy and the duration of invasive mechanical ventilation in the Intensive Care Unit at Fundación Santa Fe de Bogotá.
Detailed Description
This study compares the impact of early multimodal therapy on mechanical ventilation duration in ICU patients. It is an open-label, randomized controlled clinical trial. Patients will be assigned to e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06133504
Start Date
July 1 2025
End Date
June 1 2026
Last Update
July 9 2025
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