Actively Recruiting
Does Transcutaneous Phrenic Nerve Stimulation Prevent Diaphragm Atrophy?
Led by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Updated on 2025-03-27
80
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Dear participant Participants's patient, who is participants's first-degree relative, who is connected to a ventilator in the intensive care unit, unconscious and not authorized to give informed consent, has been invited to participate in the study titled 'Does transcutaneous phrenic nerve stimulation prevent diaphragm atrophy? In order to strengthen this muscle and prevent loss of function, investigator provide electrical stimulation between the rib cage and abdomen through the skin with the tens device, causing the muscle to contract and enabling our patient to leave the respirator early. Investigator aimed to investigate the protective effect of the tens device on the diaphragm by evaluating the diaphragm muscle with the ultrasonography device during the period when it is connected to the respirator. For this reason, the diaphragm will be contracted by giving electrical stimulation three times a day for 30 minutes with the tens device for 5 days during the period when participants's patient is connected to the respirator, and intermittent diaphragm ultrasound will be evaluated. Participants or participants's legal guardian are asked to approve the use of participants's medical records during participants's treatment in the intensive care unit, provided that participants's personal information is kept confidential. Participants will not incur any financial burden by participating in the study and participants will not receive any additional payment. Participants are free to leave the study at any time if deemed necessary, and the researcher can terminate the study if deemed necessary. The information obtained within the scope of the research can be used for scientific purposes and can be presented and published provided that the confidentiality record is respected. I have read (or orally listened to) the text above, which contains the information given to the participants before the research began. I agree to participate in the study as a Volunteer. I consent to the use of my medical information. I also understand that if I do not agree to participate in the study, my treatment will be carried out in full without interruption. Participant name and surname: Participant's relative's name and surname: Degree of closeness: Signature / Date:
CONDITIONS
Official Title
Does Transcutaneous Phrenic Nerve Stimulation Prevent Diaphragm Atrophy?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients on invasive mechanical ventilation for 72 hours or more
- Patients older than 18 years
You will not qualify if you...
- Patients under 18 years of age
- Patients with less than 72 hours of mechanical ventilation
- Pregnancy
- Patients with a body mass index above 35kg/m6
- Neuromuscular disease
- Refractory epilepsy
- Patients with pacemakers
- ARDS
- Unilateral or bilateral diaphragm paralysis
- Presence of pneumothorax
- Patients with large right pleural effusion
- Tracheostomized patients
- Patients undergoing upper abdominal surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dr.SadiKonuk EAH
Istanbul, Bakirkoy, Turkey (Türkiye)
Actively Recruiting
Research Team
S
Safiye Tuba Kaplan
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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