Early Multimodal Therapy and Mechanical Ventilation

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Time (days) from intubation to extubation. [Срок оценки: 28 days]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT06133504 · SECEC-2023-129

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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