Post-cardiac SurgeryNCT06621693
Effect of Neuromuscular Electrical Stimulation on Phrenic Nerve Regeneration Post Cardiac Surgeries
A study testing Transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy program in people with Post-cardiac Surgery, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the effect of neuromuscular electrical stimulation on phrenic regeneration post cardiac surgery Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-cardiac Surgery
- What is being tested?
- Transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Oct 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to investigate the effect of neuromuscular electrical stimulation on phrenic regeneration post cardiac surgery
Read the 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.
- Conditions
- Post-cardiac Surgery
- Being tested
- Transcutaneous electrical diaphragmatic stimulation intervention, traditional physiotherapy program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical diaphragmatic stimulation interventionDevice
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.
traditional physiotherapy programOther
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
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy group | Experimental | This group will receive transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy three times per week for 4 weeks Receives: Device: Transcutaneous electrical diaphragmatic stimulation intervention; Other: traditional physiotherapy program |
| Traditional physiotherapy group | Active comparator | This group will receive traditional physiotherapy only, three times per week for 4 weeks Receives: Other: traditional physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phrenic nerve conduction study: motor latency
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).
Measured: 4 weeks
Phrenic nerve conduction study: Amplitude
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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start4 Oct 2024 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Atef Abd El Fatah, Cairo University
- Investigators
- Hala R. Mahmoud, professor, Study director, Cairo UniversityNagwa M. Badr, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621693
- Sponsor's protocol ID
- P.T.REC/012/005299
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Electrical Stimulation on Phrenic Nerve Regeneration Post Cardiac Surgeries
- ClinicalTrials.gov ID
- NCT06621693
- Acronym / sponsor ID
- P.T.REC/012/005299
- Conditions
- Post-cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Oct 2024 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy group | Experimental | Device: Transcutaneous electrical diaphragmatic stimulation intervention, Other: traditional physiotherapy programThis group will receive transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy three times per week for 4 weeks |
| Traditional physiotherapy group | Active comparator | Other: traditional physiotherapy programThis group will receive traditional physiotherapy only, three times per week for 4 weeks |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- Patients with rib fracture.
- Patients developing lung cancer.
- Patients have dementia.
- Patients on mechanical ventilator after 24 hours
- Metabolically unstable chronic illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical diaphragmatic stimulation interventionIt 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. | Device | Transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy group |
| traditional physiotherapy programThe participants will receive traditional physiotherapy ( postural drainage, percussion , diaphragmatic breathing, phase 1 cardiac Rehabilitation and balance training ) three times per week for 4 weeks | Other | Traditional physiotherapy group, Transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy group |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hala R. Mahmoud, professor study director
Cairo University
Nagwa M. Badr, professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy program in people with Post-cardiac Surgery, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hala A. Abdel Fattah, Master (+201027551192, hala.atef1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phrenic nerve conduction study: motor latency (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.