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临床试验/NCT05846945
NCT05846945已完成不适用

Effect of Threshold Inspiratory Trainer Versus Trigger Sensitivity Adjustment on Weaning From Mechanical Ventilation

Cairo University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年8月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
partial pressure of carbon dioxide(PaCO2)

研究概览

简要总结

Ninety adult patients from both gender, with acute respiratory failure, intubated and mechanically ventilated. Their ages ranged from 50 to 70 years. They were selected from Intensive Care Unit (ICU), Department of Chest Diseases, Cairo University Hospitals. They have randomly assigned into three equal groups. Group (A): trained by threshold IMT device plus routine physical therapy. Group (B): trained by adjusting MV trigger sensitivity plus routine physical therapy. Group (C): only received routine physical therapy. (Negative inspiratory force NIF, arterial blood gases, P/F ration, respiratory rate RR, tidal volume VT, and rapid shallow breathing index RSBI) were measured before the study and at the end of the study (just before weaning for successfully weaned patients, or on the 10 day of intervention for failed weaning patients).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Their age ranged from 50-70 years.
  • •The patients were diagnosed with acute respiratory failure duo to COPD exacerbation and need mechanical ventilation support for more than 48 hours.
  • •They were vitally stable and can tolerate pressure support
  • •PEEP less than 8Cm H2O , SpO2 more than 90).
  • •All patients were conscious and responded to verbal command.

排除标准

  • •Unstable hemodynamics,
  • •unstable neurological problems,
  • •lack of attention and cooperation
  • •skipping more than five training sessions.

研究组 & 干预措施

IMT group

Active Comparator

Training by inspiratory muscle device plus chest physiotherapy

干预措施: Threshold inspiratory muscle trainer device (Other)

IMT group

Active Comparator

Training by inspiratory muscle device plus chest physiotherapy

干预措施: Chest physiotherapy (Other)

TS group

Active Comparator

Adjusting trigger sensitivity of the mechanical ventilator to the lowest pressure tolerated plus chest physiotherapy

干预措施: Adjusting mechanical ventilator trigger sensitivity (Other)

TS group

Active Comparator

Adjusting trigger sensitivity of the mechanical ventilator to the lowest pressure tolerated plus chest physiotherapy

干预措施: Chest physiotherapy (Other)

PT group

Sham Comparator

Routine chest physiotherapy

干预措施: Chest physiotherapy (Other)

结局指标

主要结局

partial pressure of carbon dioxide(PaCO2)

时间窗: change from baseline at one week

arterial blood sample was taken and examined the PaCO2

partial pressure of oxygen(PaO2)

时间窗: change from baseline at one week

arterial blood sample was taken and examined thePao2

次要结局

  • Respiratory rate (RR)(change from baseline at one week)
  • tidal volume (TV)(change from baseline at one week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heba Ahmed Ali Abdeen

Assistant Professor

Cairo University

研究点 (1)

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