Early Multimodal Therapy and Mechanical Ventilation

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Illness; Critical Care
• Intervention / Treatment: Procedure: Early Multimodal Therapy; Procedure: Late Multimodal Therapy

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 Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jorge Alvarado, MD; Phone Number: 3017858459; Email: jialvarados@unal.edu.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early arm; Early multimodal therapy is characterized by a comprehensive set of therapeutic interventions executed by the physiotherapy, speech therapy, respiratory therapy, and occupational therapy teams precisely at the moment of study inclusion. This tailored approach ensures that patients receive a coordinated and multidisciplinary therapeutic regimen right from the outset of their participation in the study	Procedure: Early Multimodal Therapy; Early multimodal therapy is defined as the collection of therapeutic maneuvers performed by the physiotherapy, speech therapy, respiratory therapy, and occupational therapy team at the time of study inclusion.
Active Comparator: Late arm; While late multimodal therapy is characterized by the same type of maneuvers carried out by the same disciplinary team but initiated once indicated by the attending physician.	Procedure: Late Multimodal Therapy; Late multimodal therapy is characterized by the same set of maneuvers carried out by the same disciplinary team, but it is initiated once indicated by the attending physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time (days) from intubation to extubation.	Days of mechanical ventilation duration	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU length of stay	ICU length of stay	28 days
Ventilator-free days until day 28	28 minus the days of mechanical ventilation	28 days
Delirium days until day 28	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).	28 days
Delirium-free days until day 28	28 minus days with presence of delirium	28 days
Sedation days until day 28.	Sedation days until day 28.	28 days
Sedation-free days until day 28	28 days minus days of sedation	28 days
Hospitalization days	Hospitalization days	90 days
Mortality from any cause up to 90 days	Mortality from any cause up to 90 days	90 days
Functional independence status measured by ADLs at hospital discharge	Activities of Daily Living (ADLs), each variable scores one point: bathing, dressing, eating, grooming, transferring from bed to chair, and using the bathroom	90 days
Functional independence status measured by ADLs at ICU discharge	Activities of Daily Living (ADLs), each variable scores one point: bathing, dressing, eating, grooming, transferring from bed to chair, and using the bathroom	28 days
Muscle strength measured using the Medical Research Council (MRC) scale	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	28 days
Swallowing difficulty at 72 hours.	Presence of dysphagia at 72 hours after extubation	28 days
Time until the initiation of oral intake	Time to initiate oral intake after extubation: 1) 12-24 hours, 2) > 24 hours	28 days
Development of healthcare-associated pneumonia	Pneumonia associated with invasive mechanical ventilation. Yes or no.	28 days
Maximum mobility measured by JH-HLM (Johns Hopkins Highest Level of Mobility) scale	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.	28 days
Grip strength	Grip strength of the dominant hand within 24 hours post-extubation. Kilograms. Score is 0 if the patient deceases	28 days
Extubation failure	Inability to breathe spontaneously in the first 48 hours after removal of artificial airway, and the patient is unable to maintain a patent airway	28 days
Need for non-invasive mechanical ventilation	Need for non-invasive mechanical ventilation: Yes or No	28 days
Cognitive function measured using the Montreal Cognitive Assessment (MOCA).	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	90 days
Barthel Index at hospital discharge	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.	28 days

Collaborators and Investigators

• Sponsor: Fundación Santa Fe de Bogota

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: SECEC-2023-129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No