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Does Transcutaneous Phrenic Nerve Stimulation Prevent Diaphragm Atrophy?

NCT06897774 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-03-27

No results posted yet for this study

Summary

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

  • Critical Care, Intensive Care

Sponsors & Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-22
Primary Completion
2025-04-22
Completion
2025-04-22

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06897774 on ClinicalTrials.gov