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Not yet recruiting NCT06133504

Early Multimodal Therapy and Mechanical Ventilation

No phase Interventional Critical Care Critical Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early Multimodal Therapy, Late Multimodal Therapy.
Who it may be relevant to
Registry conditions: Critical Care, Critical Illness. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Time (days) from intubation to extubation. [Time frame: 28 days]
Secondary outcome measures (12)
  • Ventilator-free days until day 28 [Time frame: 28 days]
  • Delirium days until day 28 [Time frame: 28 days]
  • Delirium-free days until day 28 [Time frame: 28 days]
  • Sedation days until day 28. [Time frame: 28 days]
  • Sedation-free days until day 28 [Time frame: 28 days]
  • Barthel Index at hospital discharge [Time frame: 28 days]
  • Hospitalization days [Time frame: 90 days]
  • ICU length of stay [Time frame: 28 days]
  • Mortality from any cause up to 90 days [Time frame: 90 days]
  • Functional independence status measured by ADLs at hospital discharge [Time frame: 90 days]
  • Functional independence status measured by ADLs at ICU discharge [Time frame: 28 days]
  • Muscle strength measured using the Medical Research Council (MRC) scale [Time frame: 28 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 PMID 40388519

Identifiers

NCT: NCT06133504 · SECEC-2023-129

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗