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

Not Applicable

Not yet recruiting

• Conditions: Post-cardiac Surgery
• Interventions: Device: Transcutaneous electrical diaphragmatic stimulation intervention; Other: traditional physiotherapy program

• Registration Number: NCT06621693
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-29
• Study First Submitted QC: 2024-09-29
• Last Update Submitted: 2024-09-29
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01
• Study Start: 2024-10-04
• Primary Completion: 2025-01-15
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy group	traditional physiotherapy program	This group will receive transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy three times per week for 4 weeks
Traditional physiotherapy group	traditional physiotherapy program	This group will receive traditional physiotherapy only, three times per week for 4 weeks
Transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy group	Transcutaneous electrical diaphragmatic stimulation intervention	This group will receive transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy three times per week for 4 weeks

Primary Outcome Measures

Name	Time	Method
Phrenic nerve conduction study: motor latency	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	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).

Trial Locations

Locations (1)

Hala Atef Abdel Fattah; 🇪🇬 Cairo, Egypt