Early Multimodal Therapy and Mechanical Ventilation

NCT ID: NCT06133504

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2026-06-30

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

Conditions

Critical Care; Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Early Multimodal Therapy

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Late Multimodal Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Santa Fe de Bogota

OTHER

Sponsor Role: lead

Responsible Party

Jorge Iván Alvarado

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jorge Alvarado, MD

Role: CONTACT

jialvarados@unal.edu.co

3017858459

References

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.

Reference Type: DERIVED

PMID: 40388519 (View on PubMed)

Other Identifiers

SECEC-2023-129

Identifier Type: -

Identifier Source: org_study_id