Early Multimodal Therapy and Mechanical Ventilation

N/ANot Yet RecruitingNCT06133504

Fundación Santa Fe de Bogota74 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Critical Care Critical Illness

Interventions

Early Multimodal TherapyPROCEDURE

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 Multimodal TherapyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Time (days) from intubation to extubation.

Days of mechanical ventilation duration

Time frame: 28 days

Secondary Outcomes

Ventilator-free days until day 28

28 minus the days of mechanical ventilation

Time frame: 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).

Time frame: 28 days

Delirium-free days until day 28

28 minus days with presence of delirium

Time frame: 28 days

Sedation days until day 28.

Time frame: 28 days

Sedation-free days until day 28

28 days minus days of sedation

Time frame: 28 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.

Time frame: 28 days

Hospitalization days

Time frame: 90 days

Central Contacts

Jorge Alvarado, MD

CONTACT

3017858459 jialvarados@unal.edu.co

Data from ClinicalTrials.gov

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