Early Multimodal Therapy and Mechanical Ventilation

NCT06133504 | Not Yet Recruiting

• 1 other identifier: SECEC-2023-129
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critical Care; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Time (days) from intubation to extubation.

  Days of mechanical ventilation duration

  28 days

Secondary Outcomes (20)

• Ventilator-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

• Sedation-free days until day 28

  28 days

Study Arms (2)

Early arm

ACTIVE COMPARATOR

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

Late arm

ACTIVE COMPARATOR

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

Interventions

Early Multimodal Therapy PROCEDURE

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.

Early arm

Late Multimodal Therapy PROCEDURE

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.

Late arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Santa Fe de Bogota: lead

Related Publications (1)

• Alvarado Sanchez JI, Castillo Morales LM, Cardenas Bolivar YR, Montanez Narino V, Stozitzky Rios MV, Arevalo Guerrero CL, Pulido Bobadilla ML, Melo Rojas DM, Lopez Rubio AG, Ortiz Moreno DC, Barreto Garzon PA, Murillo M, Mora-Salamanca AF. Efficacy and safety of the early implementation of a multimodal rehabilitation program in mechanically ventilated patients: A randomized clinical trial protocol. PLoS One. 2025 May 19;20(5):e0324335. doi: 10.1371/journal.pone.0324335. eCollection 2025.

  PMID: 40388519 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jorge Alvarado, MD

CONTACT

3017858459; jialvarados@unal.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The study is a phase III randomized clinical trial at a single center with two patient groups, "early arm" (EA) and "late arm," assigned through stratified randomization. Allocation concealment uses sealed envelopes. EA includes intubated patients receiving early multimodal therapy, while the "late arm" starts therapy during ventilatory support weaning. Blinding isn't feasible, but final assessments at 90 days are blinded to intervention groups. Statisticians analyze data blinded. The study is intention-to-treat based, ensuring a comprehensive evaluation of intervention effectiveness

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share