NCT06133504尚未招募不适用
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
Fundación Santa Fe de Bogota0 个研究点目标入组 74 人开始时间: 2025年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 主要终点
- Time (days) from intubation to extubation.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Time (days) from intubation to extubation.
时间窗: 28 days
Days of mechanical ventilation duration
次要结局
- ICU length of stay(28 days)
- Ventilator-free days until day 28(28 days)
- Sedation-free days until day 28(28 days)
- Delirium days until day 28(28 days)
- Delirium-free days until day 28(28 days)
- Sedation days until day 28.(28 days)
- Barthel Index at hospital discharge(28 days)
- Hospitalization days(90 days)
- Mortality from any cause up to 90 days(90 days)
- Functional independence status measured by ADLs at hospital discharge(90 days)
- Swallowing difficulty at 72 hours.(28 days)
- Functional independence status measured by ADLs at ICU discharge(28 days)
- Muscle strength measured using the Medical Research Council (MRC) scale(28 days)
- Time until the initiation of oral intake(28 days)
- Development of healthcare-associated pneumonia(28 days)
- Maximum mobility measured by JH-HLM (Johns Hopkins Highest Level of Mobility) scale(28 days)
- Grip strength(28 days)
- Extubation failure(28 days)
- Need for non-invasive mechanical ventilation(28 days)
- Cognitive function measured using the Montreal Cognitive Assessment (MOCA).(90 days)
- Time until the initiation of oral intake(28 days)
- Development of healthcare-associated pneumonia(28 days)
- Maximum mobility measured by JH-HLM (Johns Hopkins Highest Level of Mobility) scale(28 days)
- Grip strength(28 days)
- Extubation failure(28 days)
- Need for non-invasive mechanical ventilation(28 days)
- Cognitive function measured using the Montreal Cognitive Assessment (MOCA).(90 days)
- Swallowing difficulty at 72 hours.(28 days)
- Ventilator-free days until day 28(28 days)
- Delirium days until day 28(28 days)
- Delirium-free days until day 28(28 days)
- Sedation days until day 28.(28 days)
- Sedation-free days until day 28(28 days)
- Hospitalization days(90 days)
- ICU length of stay(28 days)
- Mortality from any cause up to 90 days(90 days)
- Functional independence status measured by ADLs at hospital discharge(90 days)
- Functional independence status measured by ADLs at ICU discharge(28 days)
- Muscle strength measured using the Medical Research Council (MRC) scale(28 days)
研究者
Jorge Iván Alvarado
Principal investigator
Fundación Santa Fe de Bogota
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