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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06621693
Enrollment
60
Registered
2024-10-01
Start date
2024-10-04
Completion date
2025-01-30
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-cardiac Surgery

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.

Interventions

DEVICETranscutaneous electrical diaphragmatic stimulation intervention

It will be applied on diaphragm, 30 min per session ,3 days/week for 4 weeks at a stimulation frequency of 30 Hz, pulse width of 400 μs, the intensity was gradually increased until visible muscle contraction was observed.

The participants will receive traditional physiotherapy ( postural drainage, percussion , diaphragmatic breathing, phase 1 cardiac Rehabilitation and balance training ) three times per week for 4 weeks

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Phrenic nerve conduction study: motor latency4 weeksNihon 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: Amplitude4 weeksNihon 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).

Countries

Egypt

Contacts

Primary ContactHala A. Abdel Fattah, Master
hala.atef1996@gmail.com+201027551192
Backup ContactRana H. El Banaa, PHD
rana.elbanna@yahoo.com+201062070686

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026