Does Transcutaneous Phrenic Nerve Stimulation Prevent Diaphragm Atrophy?

NCT06897774 | Recruiting

• 1 other identifier: z2g6egpa
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Primary Outcome: Diaphragm atrophy, ventilator-associated diaphragm dysfunction

  By performing phrenic nerve stimulation with TEDS device, the thickness change in the diaphragm muscle will be measured by usg at the end of 5 days. The thickness of the diaphragm muscle will be measured in inspiratory and expiratory. Atrophy will be determined according to the change in thickness. Diaphragm thickening fraction will be calculated by formilizing the thickness in inspiratory and expiratory and diaphragm dysfunction will be determined.DTF (End-inspiratory thickness - End-expiratory thickness)/ End-expiratory thickness)x100. The following values will be accepted for the results. Diaphragmatic Atrophy: Diaphragm thickness\<1-1.5cm Diaphragmatic thickness decreased by 10% compared to baseline Diaphragmatic Dysfunction: Diaphragmatic Thickening Fraction \<20

  January 22 2024-April 22 2025

Secondary Outcomes (1)

• 1.Duration of Mechanical Ventilation 2.Length of Stay in Intensive Care Unit

  January 22 2024-April 22 2025

Study Arms (2)

Early Group

The group in which transcutaneous electrical nerve stimulation will be inserted immediately after intubation

Late Group

The group to be fitted with transcutaneous electrical nerve stimulation 48 hours after intubation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients on invasive mechanical ventilation for 72 hours or more Patients older than 18 years

You may not qualify if:

• Patients with less than 72 hours of mechanical ventilation
• Pregnancy
• Patients with a body mass index above 35kg/m²
• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Dr.SadiKonuk EAH

Istanbul, Bakirkoy, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Safiye Tuba Kaplan

CONTACT

+9; sipahituba79@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 27, 2025
• Study Start: January 22, 2024
• Primary Completion: April 22, 2025
• Study Completion: April 22, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

TU (1)