Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Oxygenation index
研究概览
简要总结
Evaluation of the effect of pulmonary rehabilitation on patients with high flow oxygen therapy
详细描述
Objective
the purpose of this study was to evaluate the effect of lung rehabilitation on patients treated with high flow humidification apparatus in ICU. Methods: 70 patients in ICU who were treated with high flow humidification apparatus from June 2019 to June 2020 were randomly divided into two groups. The experimental group was treated with pulmonary rehabilitation and the control group was treated with routine medical treatment only. All patients were evaluated and measured by bedside diaphragm ultrasound. The vital signs of all patients were monitored every day. MRCsum assessment of peripheral muscle strength, 30s sitting test, modified Barthel index, Borg dyspnea score, arterial blood gas analysis and bedside diaphragm ultrasound monitoring were performed at admission and discharge. Finally, statistics were made on the use of non-invasive ventilator, endotracheal intubation, new complications (pressure sore, aspiration, thrombus, etc.) and the time of patients getting out of bed for the first time.The end point of the experiment was 28 days.
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
- Double (Participant, Care Provider)
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 age is ≥ 18 years old;
- •the hemodynamics is stable;
- •50 < heart rate < 120 beats / min ;
- •90 < systolic blood pressure < 200mmHg ;
- •55 < mean arterial pressure < 120mmHg;
- •do not increase the dose of pressor drugs for at least 2 hours;
- •intracranial pressure is stable and there are no seizures within 24 hours;
- •the respiratory state is stable;
- •the patient's finger pulse oxygen saturation ≥ 88%;
- •10 < respiratory frequency < 35 beats / min.
排除标准
- •Pregnancy;
- •acute cardio-cerebrovascular events;
- •spinal or limb fractures;
- •active bleeding.
研究组 & 干预措施
Experimental group
Pulmonary rehabilitation therapy
干预措施: Pulmonary rehabilitation therapy (Behavioral)
Control group
Routine medical treatment
结局指标
主要结局
Oxygenation index
时间窗: Day 28
arterial partial pressure of oxygen divided by the oxygen concentration,Normal is greater than 400.
PaO2
时间窗: Day 28
arterial partial pressure of oxygen,Partial pressure of oxygen in arterial blood,normal range is 80\~100.
End-inspiratory diaphragm thickness
时间窗: Day 28
The thickness of the diaphragm during inhalation,The thickness of diaphragm at the end of expiratory is about 0.25cm.
Diaphragm contraction velocity
时间窗: Day 28
The rate at which the diaphragm contracts during inhalation,normal is 1.3cm/s.
MRC
时间窗: Day 28
Medical Research Council,Muscle strength assessment,total points0\~60，less than 48scores means ICU aquired weaknesses.
STS
时间窗: Day 28
Number of sit-to-stand test in 30s,Muscle endurance assessment,The more times, has the better muscular endurance.
barthel index
时间窗: Day 28
barthel index,Daily activity assessment,Assessment of activities of daily living.total points0\~100，less than 60 scores means can't independent living.
Borg dyspnea score
时间窗: Day 28
Borg dyspnea score,Maximum 10 points,Minimum 0,The higher the score, the harder it is to breathe
End-expiratory diaphragm thickness
时间窗: Day 28
The thickness of the diaphragm during exhalation,The thickness of diaphragm at the end of expiratory is about 0.15cm.
Diaphragm mobility
时间窗: Day 28
The distance the diaphragm drops during inhalation,normal is 1.4cm.
Diaphragm thickness variation rate
时间窗: Day 28
Rate of diaphragmatic thickness change during breathing,Diaphragmatic dysfunction is considered less than 20%.
次要结局
- Intubation(Day 28)
- Complication(Day 28)
- Hospitalization time(Month 3)
- The time it takes to get out of bed for the first time(Day 28)
- Use of non-invasive ventilator(Day 28)
- mortality(Day 28)
- ICU stay time(3 month)
研究者
wang kaifei
Ph.D.
Chinese PLA General Hospital