Comparison of the Benefits of Different Types of Wearable Respirator Support Devices for Critically Ill Patients in the ICU During Early Mobilization
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- removal time
研究概览
简要总结
Assisting critically ill patients with early mobilization or early ambulation during their stay in the intensive care unit (ICU) can reduce the duration of mechanical ventilation use, length of ICU or hospital stay, probability of complications during hospitalization, and sedation days in the ICU and improve disease prognosis. However, over 80% of critically ill patients have endotracheal tubes and require the use of mechanical ventilators in the ICU, and due to the numerous invasive treatments and tubes, there are high concerns regarding the safety of tube stability and risk of tube dislodgement during early mobilization. Although there are commercially available fixed tracheal tubes or external support devices for breathing tubes to prevent displacement, they do not solve the problems of the weight of the breathing tube during ambulation or endotracheal tube slippage. Therefore, through interdisciplinary collaboration, the investigator has designed a "wearable support device" (Type A support device). The unique design of the fixed frame uses a plug-in-latch shape to fix the Y-shaped breathing tube to the patient's chest position. In addition to reducing the displacement of the free section of the endotracheal tube downwards, it can also fix the main body of the breathing tube. The dual-disc strap method allows adjustment of the position and tightness for patients of different body sizes, and a single specification can be used for patients of various body shapes. Currently, a modified version of this wearable support device (Type B support device) has been designed based on clinical suggestions.The purpose of this study is to compare the feasibility, safety, and comfort of using the Type A-support device and the Type B-support device to assist in supporting breathing tubes during early ambulation in ICU patients using mechanical ventilators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glasgow Coma Scale score of ≥6,
- •relatively stable respiratory status (oxygen saturation >92%, settings on the mechanical ventilator: fraction of inspired oxygen ≤60%, positive end-expiratory pressure ≤10 cmH2O)
- •a stable cardiovascular system (resting heart rate ≤130 and >40 beats per minute)
- •no requirement for high-dose vasopressors >0.2 μg/kg/min).
排除标准
- •Patients with temporary limb immobilization as prescribed by the physician.
- •Patients with a tendency to bleed.
- •Patients with pre-existing mental abnormalities.
- •Patients who are expected to die within the next 24 hours or are primarily receiving palliative care in the intensive care unit.
- •Patients with sustained intracranial pressure elevation (> 20 millimeters of mercury (mmHg)).
- •Pregnant patients.
- •Uncontrolled epilepsy.
- •Acute myocardial infarction or rapidly progressing neuromuscular diseases occurring in the intensive care unit.
- •Patients with abnormal skin conditions such as skin abrasions, redness, swelling, etc., in the chest/back area.
结局指标
主要结局
removal time
时间窗: From date of randomization up to 5 days
the time taken to remove support device
wearing time
时间窗: From date of randomization up to 5 days
the time taken to wear support device
次要结局
- user self-reported function, and device satisfaction(From date of randomization up to 5 days)
- adverse event(From date of randomization up to 5 days)
- 5-min heart rate variability (HRV)(From date of randomization up to 5 days)
- mean values of the rapid shallow breathing index (RSBI)(From date of randomization up to 5 days)