Early Multimodal Therapy and Mechanical Ventilation

Fundación Santa Fe de Bogota

Status: Not yet enrolling

Conditions: Critical Care; Critical Illness

Treatments: Procedure: Late Multimodal Therapy; Procedure: Early Multimodal Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06133504

SECEC-2023-129

Details and patient eligibility

About

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.

Full 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

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Early arm

Active Comparator group

Description:

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

Treatment:

Procedure: Early Multimodal Therapy

Late arm

Active Comparator group

Description:

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.

Treatment:

Procedure: Late Multimodal Therapy