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临床试验/NCT05159401
NCT05159401已完成不适用

The Use of Vibrational Methods of Influencing the Lungs to Restore Their Functional State After Major Reconstructive Cardiac Surgery

Petrovsky National Research Centre of Surgery1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
240
试验地点
1
主要终点
the minute inspiratory lung volume

研究概览

简要总结

There will be formed of groups for application of vibration methods on the lungs: the method of vibroacoustic lung massage using the "BARK VibroLUNG" device; the method of oscillating PEP therapy using Acapella DH Green; the method of hardware stimulation of cough with a mechanical insufflator-aspirator Comfort Cough Plus (Comfortable cough Plus). As a control group, classical manual chest massage with percussion and verbal stimulation of cough against the background of chest compressions with a total duration of 15 minutes will be used

详细描述

The patient signs an informed consent to participate in the study after 10-12 hours tracheal extubation and transfer of the patient to spontaneous respiration. The application of one or another method of influence is carried out by the method of random sampling (the envelope method). Next, a session is conducted using one of the methods of vibrational respiratory therapy. We are exploring the gas composition of arterial blood is examined, spirometry, and the respiratory rate is measured after 20 minutes of the procedure. Further, respiratory therapy sessions are repeated 3 times a day for three days

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
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

入选标准

  • Age from 18 years to 80 years inclusive.
  • Performed cardiac surgery in IC conditions.
  • The patient's consent to participate in this study.

排除标准

  • Lack of productive contact with the patient
  • Any disorder in the central nervous system in the perioperative period (acute cerebrovascular accident, coma, posthypoxic encephalopathy), being on a ventilator.
  • Unstable hemodynamics or hemodynamically significant rhythm disturbances
  • Shocks of various etiologies
  • Inability to provide respiratory protection, high risk of aspiration
  • Refusal of the patient to participate in this study

结局指标

主要结局

the minute inspiratory lung volume

时间窗: hospitalisation period, an average of 1 week

Comparison of minute inspiratory lung volume befor/after research using a spirometer

arterial blood oxygenation level

时间窗: hospitalisation period, an average of 1 day

Comparison arterial blood oxygenation level before/after researchin the study of arterial blood

SpO2 more than 92%

时间窗: hospitalisation period, an average of 3 day

Comparison of SpO2 by pulse oximeter befor/after research (SpO2\>92%)

次要结局

  • the number of complications(hospitalisation period, an average of 1 week)
  • assessment of the duration of hospital stay(hospitalisation period, an average of 1 week)

研究者

发起方
Petrovsky National Research Centre of Surgery
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleksandr Eremenko

Clinical Professor

Petrovsky National Research Centre of Surgery

研究点 (1)

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