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临床试验/NCT06621693
NCT06621693尚未招募不适用

Effect of Neuromuscular Electrical Stimulation on Phrenic Nerve Regeneration Post Cardiac Surgeries

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Phrenic nerve conduction study: motor latency

研究概览

简要总结

This study will be conducted to investigate the effect of neuromuscular electrical stimulation on phrenic regeneration post cardiac surgery

详细描述

Phrenic nerve injury post cardiac surgery is a serious problem closely related to frequent respiratory complications. It has been associated with diaphragm dysfunction, pneumonia and difficulty weaning from mechanical ventilation in critical ill patients.

Neuromuscular electrical stimulation (NMES) is commonly used in physical therapy to increase muscle strength and promote muscle hypertrophy.

There is increased flow of patients after heart surgery in kasr Aini hospital who suffers from respiratory complication due to phrenic nerve injury so the hospitalization period of them increased which make economic burden in health insurance services with decreased level of quality of life that is the most concern as to improve patient status and relief this burden. So this study aims to decrease respiratory complication and improve phrenic nerve regeneration by using neuromuscular electrical stimulation as a safe, noninvasive , inexpensive and virtually risk free method.

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 (Outcomes Assessor)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients post cardiac surgery (coronary artery bypass graft, valve repair or replacement ).
  • Patients referred by physician.
  • Medically stable patients.
  • Both genders
  • Ages from 25 to 45
  • BMI 25-29.9 kg/m2
  • Able to understand the requirements of the study.
  • Conscious patient and respond to verbal commands.

排除标准

  • Participants will be excluded if they meet one of the following criteria:
  • Patients with rib fracture.
  • Patients developing lung cancer.
  • Patients have dementia.
  • Patients on mechanical ventilator after 24 hours
  • Metabolically unstable chronic illness

结局指标

主要结局

Phrenic nerve conduction study: motor latency

时间窗: 4 weeks

Nihon Kohden Neuropak M1 MEB-9200 EMG machine, made in Japan will be used to measure phrenic nerve conduction study. Motor latency is the impulse traveled from the stimulation site to the recording site is called latency and it is measured in milliseconds (ms). its normal value: (5.74ms -7.10 ms).

Phrenic nerve conduction study: Amplitude

时间窗: 4 weeks

Nihon Kohden Neuropak M1 MEB-9200 EMG machine, made in Japan will be used to measure phrenic nerve conduction study. Amplitude represents the maximal action potential depolarization and voltage gradient for all depolarized fibers of the phrenic nerve. it is measured in microvolt or millivolt (mv). its normal value: (0.47 mv-0.83 mv).

次要结局

未报告次要终点

研究者

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

Hala Atef Abd El Fatah

Principal investigator

Cairo University

研究点 (1)

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