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临床试验/NCT04441151
NCT04441151
招募中
不适用

Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 70 人2025年3月20日

概览

阶段
不适用
干预措施
Pulmonary rehabilitation therapy
疾病 / 适应症
Pulmonary Disease
发起方
Chinese PLA General Hospital
入组人数
70
试验地点
1
主要终点
Oxygenation index
状态
招募中
最后更新
2个月前

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.

注册库
clinicaltrials.gov
开始日期
2025年3月20日
结束日期
2026年2月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Chinese PLA General Hospital
责任方
Principal Investigator
主要研究者

wang kaifei

Ph.D.

Chinese PLA General Hospital

入排标准

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

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)

研究点 (1)

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