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临床试验/NCT04368286
NCT04368286Unknown不适用

Effects of Respiratory Rehabilitation on Patients After Extubation

Chinese PLA General Hospital0 个研究点目标入组 100 人开始时间: 2020年12月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Reintubation rates

研究概览

简要总结

Effects of respiratory rehabilitation on patients after extubation

详细描述

The purpose of this study is to evaluate whether sequential treatment with high-flow humidification therapy apparatus can improve the postoperative recovery and functional status of patients with invasive mechanical ventilation in ICU after the withdrawal of the catheter.Inclusion criteria: age 18-95;The hemodynamics were stable, that is, 50 < heart rate less than 120 beats/min, 90 < systolic blood pressure < 200mmHg, 55 < mean arterial pressure < 120mmHg.Do not increase the dose of vasopressor for at least 2 hours;Intracranial pressure was stable and there was no seizure within 24 hours.The breathing condition was stable, that is, the oxygen satiety of the patient's finger vein was ≥88%, and the breathing frequency was >10 and< 35 times/min.Exclusion criteria: pregnancy;Acute myocardial infarction.A total of 50 patients who are sequentially treated with high-flow humidification therapy apparatus after extubation in ICU are randomly assigned. The experimental group receive respiratory rehabilitation therapy, while the control group only receive routine medical treatment. All the enrolled patients underwent rehabilitation evaluation and bedside diaphragmatic ultrasound measurement.This study was approved by the Ethics Committee of the CPLA General Hospital (project No.2018-212-01). The following clinical datas were recorded for all patients through the unified database software: The rehabilitation program was formulated according to the cluster management strategy of ABCDEF and the six-step method of early activities.All of the patients in monitoring vital signs, every day at hospital group and all peripheral muscle MRC assessment, 30 s sit stand trial, modified Barthel index, Borg dyspnea score, arterial blood gas analysis, diaphragm ultrasonic monitoring by the bed, finally the experimental process on the patients whether using noninvasive ventilator, whether for endotracheal intubation again, whether to have new complications (pressure sores, aspiration, thrombosis, etc.) and the patients bed time statistics for the first time. Statistical analyses were conducted by SPSS 21.0 and a two-tailed P < 0.05 was considered significant.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged above 18
  • The hemodynamics are stable
  • 50 < heart rate less than 120 beats/min
  • 90 < systolic blood pressure < 200mmHg
  • 55 < mean arterial pressure < 120mmHg
  • Do not increase the dose of vasopressor for at least 2 hours
  • Intracranial pressure was stable and there is no seizure within 24 hours
  • The breathing condition is stable
  • the oxygen satiety of the patient's finger vein is ≥88%
  • 10<the breathing frequency < 35 times/min

排除标准

  • Pregnancy
  • Acute myocardial infarction (ami)

结局指标

主要结局

Reintubation rates

时间窗: 28 days

The artificial airway was established again for invasive mechanical ventilation

次要结局

  • 30-STS(28 days)
  • The diaphragmatic excursion(28 days)
  • mortality(28 days)
  • MRC,medical research council(28 days)
  • diaphragm thickness diaphragm thickness fraction(28 days)
  • LOS(length of stay)(three months)
  • First time out of bed(three months)
  • Barthel(28 days)
  • oxygenation index(28 days)
  • length of stay in ICU(three months)
  • Noninvasive utilization rate(28 days)
  • Borg dyspnea score(28 days)
  • diaphragm contraction rate(28 days)
  • Complication rate(28 days)
  • oxygen partial pressure(28 days)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

wang kaifei

Principal Investigator

Chinese PLA General Hospital

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