Early Multimodal Therapy and Mechanical Ventilation

Not Applicable

Not yet recruiting

• Conditions: Critical Illness; Critical Care

• Registration Number: NCT06133504
• Lead Sponsor: Fundación Santa Fe de Bogota

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

Study Timeline

• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-10
• Study First Posted: 2023-11-15
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-09
• Primary Completion: 2026-06
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time (days) from intubation to extubation.	28 days	Days of mechanical ventilation duration

Secondary Outcome Measures

Name	Time	Method
Ventilator-free days until day 28	28 days	28 minus the days of mechanical ventilation
Sedation-free days until day 28	28 days	28 days minus days of sedation
Delirium days until day 28	28 days	In order for a patient to be considered to have delirium according to the CAM-ICU, the first criterion (acute change in mental status) must be present, along with at least one of the other three criteria (inability to maintain sustained attention, disorganized thinking, or fluctuating levels of consciousness).
Delirium-free days until day 28	28 days	28 minus days with presence of delirium
Sedation days until day 28.	28 days	Sedation days until day 28.
ICU length of stay	28 days	ICU length of stay
Barthel Index at hospital discharge	28 days	The Barthel Index is a scale used to measure the degree of functional independence in activities of daily living (ADLs) for an individual. The score is 0 if the patient deceases.
Hospitalization days	90 days	Hospitalization days
Mortality from any cause up to 90 days	90 days	Mortality from any cause up to 90 days
Functional independence status measured by ADLs at hospital discharge	90 days	Activities of Daily Living (ADLs), each variable scores one point: bathing, dressing, eating, grooming, transferring from bed to chair, and using the bathroom
Swallowing difficulty at 72 hours.	28 days	Presence of dysphagia at 72 hours after extubation
Functional independence status measured by ADLs at ICU discharge	28 days	Activities of Daily Living (ADLs), each variable scores one point: bathing, dressing, eating, grooming, transferring from bed to chair, and using the bathroom
Muscle strength measured using the Medical Research Council (MRC) scale	28 days	Muscle strength assessment in critical care patients using the Medical Research Council (MRC) scale: 5: Normal - Full range of motion against total resistance 4+: Good (+) - Full range of motion against gravity and strong resistance 4: Good (-) - Full range of motion against gravity and minimal resistance 3+: Fair (+) - Full range of motion against gravity only 3: Fair (-) - Partial range of motion against gravity 2: Poor - Movement with gravity eliminated; 1: Minimal - Visible muscle contraction without movement 0: Absent - Total paralysis
Time until the initiation of oral intake	28 days	Time to initiate oral intake after extubation: 1) 12-24 hours, 2) \> 24 hours
Development of healthcare-associated pneumonia	28 days	Pneumonia associated with invasive mechanical ventilation. Yes or no.
Maximum mobility measured by JH-HLM (Johns Hopkins Highest Level of Mobility) scale	28 days	Mobility assessment using the JH-HLM (Johns Hopkins Highest Level of Mobility) scale: 8: Walks more than 250 feet. 7: Walks more than 25 feet. 6: Walks more than 10 steps. 5: Stands for more than one minute. 4: Can move to the chair. 3: Can sit on the edge of the bed. 2: Can turn in bed.; 1: Can only lie down. Score is 0 if the patient deceases.
Grip strength	28 days	Grip strength of the dominant hand within 24 hours post-extubation. Kilograms. Score is 0 if the patient deceases
Extubation failure	28 days	Inability to breathe spontaneously in the first 48 hours after removal of artificial airway, and the patient is unable to maintain a patent airway
Need for non-invasive mechanical ventilation	28 days	Need for non-invasive mechanical ventilation: Yes or No
Cognitive function measured using the Montreal Cognitive Assessment (MOCA).	90 days	The variable is the cognitive function, assessed using the Montreal Cognitive Assessment (MOCA). This tool measures various cognitive domains, providing insight into an individual's cognitive abilities and identifying potential cognitive impairment