Early Occupational Therapy in Mechanical Ventilated Patients With Covid-19: Multicentre Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Functional independence at hospital discharge
研究概览
简要总结
This study evaluates the feasibility of an early occupational therapy (OT) protocol in critical adult patients requiring mechanical ventilation with Covid-19.
详细描述
A randomized clinical trial with an experimental-control will be implemented, considering the prospective multicenter group, with parallel groups, in a 1:1 ratio, in 3 Chilean hospitals.
A control group will has a standard analgesia, sedation, delirium and mobilization (ASDM) measures or an intervention group will have early OT plus ASDM.
The intervention group will receive 20 OT sessions, which considers a predefined protocol of actions according to the patient's condition
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
In this study, researchers, recruiters, evaluators, control group team and data analyst will be masked. These teams will not have contact with the interventionists of the experimental group. Evaluators who have contact with the patients of both groups, they will be professionals from other medical units, who do not know the ICU team, and will only be able to maintain their dialog, according to the guideline of each evaluation.
It is not possible to mask the treating occupational therapist and patient receiving OT.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age equal to or greater than 18 years.
- •Need for hospitalization in ICU.
- •At least 12 h of invasive mechanical ventilation
- •Informed consent signed by legal representative and / or patient.
- •Positive covid-19 diagnosis
排除标准
- •Known cognitive impairment before admission with short IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly) Scores> 3.3 were excluded.
- •Previous functional impairment, FAQ (Functional Activities Questionnaire) defined as > 6 points.
- •Severe communication disorder and cultural limitation of language (language different from Spanish)
- •Patient with limited therapeutic proportionality.
- •Neurocritical patients (moderate-severe Traumatic Brain Injury / stroke of some kind / among others)
- •Spinal injury or unstable fractures that limit mobilization
结局指标
主要结局
Functional independence at hospital discharge
时间窗: Day 28 (+/- 3 days) from beginning of mechanical ventilation
The FIM (Functional independence measure) instrument will be applied by evaluator team. This scale shows that higher score is better, which will be compared between control and experimental group
次要结局
- Coma-free days(Defined as the number of days in the first 14 days with the SAS.)
- Cognitive status of patients(Day 28 (+/- 3 days) from beginning of mechanical ventilation and day 90 (+/- 7 days)after hospital discharge)
- Characterization of occupational therapy interventions(Days of patient hospitalization)
- Delirium-free days(Defined as the number of days in the first 14 days with the CAM-ICU instrument negative and non-coma day.)
- Functional independence at hospital discharge(Day 90 (+/- 7 days) from beginning of mechanical ventilation)
- Motor status of patients(Day 28 (+/- 3 days) from beginning of mechanical ventilation)
- Delirium-coma free days(Defined as the number of days in the first 14 days with the SAS and CAM-ICU)
- Quality of life of patients(Day 90 (+/- 7 days) from beginning of mechanical ventilation)
研究者
Eduardo Tobar
Associated professor
University of Chile