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Clinical Trials/NCT06621693
NCT06621693
Not Yet Recruiting
N/A

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

Cairo University1 site in 1 country60 target enrollmentOctober 4, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Post-cardiac Surgery
Sponsor
Cairo University
Enrollment
60
Locations
1
Primary Endpoint
Phrenic nerve conduction study: motor latency
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 4, 2024
End Date
January 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hala Atef Abd El Fatah

Principal investigator

Cairo University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Phrenic nerve conduction study: motor latency

Time Frame: 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

Time Frame: 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).

Study Sites (1)

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