Association Between Early Multimodal Therapy and Mechanical Ventilation Days in the Intensive Care Unit at Fundación Santa Fe de Bogotá: A Randomized Controlled Clinical Trial

Fundación Santa Fe de Bogota0 sites74 target enrollmentJuly 1, 2025

ConditionsCritical Care Critical Illness

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Critical Care
Sponsor: Fundación Santa Fe de Bogota
Enrollment: 74
Primary Endpoint: Time (days) from intubation to extubation.
Status: Not yet recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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 either early multimodal therapy or standard therapy (control) in a 1:1 ratio. Blinding is not possible due to the study design. The analysis will follow an intention-to-treat approach. The hypothesis is that early multimodal therapy reduces mechanical ventilation duration

Registry

clinicaltrials.gov

Start Date

July 1, 2025

End Date

June 1, 2026

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fundación Santa Fe de Bogota

Responsible Party

Principal Investigator

Jorge Iván Alvarado

Principal investigator

Fundación Santa Fe de Bogota

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.

Outcomes

Primary Outcomes

Time (days) from intubation to extubation.

Time Frame: 28 days

Days of mechanical ventilation duration

Secondary Outcomes

ICU length of stay(28 days)
Ventilator-free days until day 28(28 days)
Sedation-free days until day 28(28 days)
Delirium days until day 28(28 days)
Delirium-free days until day 28(28 days)
Sedation days until day 28.(28 days)
Barthel Index at hospital discharge(28 days)
Hospitalization days(90 days)
Mortality from any cause up to 90 days(90 days)
Functional independence status measured by ADLs at hospital discharge(90 days)
Swallowing difficulty at 72 hours.(28 days)
Functional independence status measured by ADLs at ICU discharge(28 days)
Muscle strength measured using the Medical Research Council (MRC) scale(28 days)
Time until the initiation of oral intake(28 days)
Development of healthcare-associated pneumonia(28 days)
Maximum mobility measured by JH-HLM (Johns Hopkins Highest Level of Mobility) scale(28 days)
Grip strength(28 days)
Extubation failure(28 days)
Need for non-invasive mechanical ventilation(28 days)
Cognitive function measured using the Montreal Cognitive Assessment (MOCA).(90 days)