Transcutaneous phrenic nerve stimulation to prevent diaphragm atrophy in ICU patients
Does Transcutaneous Phrenic Nerve Stimulation Prevent Diaphragm Atrophy?
This study is testing if a special electrical stimulation can help prevent diaphragm weakness in ICU patients on ventilators for a long time, making it easier for them to breathe on their own again.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Bakirkoy Dr. Sadi Konuk Research and Training Hospital Government |
| Locations | 1 site (Istanbul, Bakirkoy) |
| Trial ID | NCT06897774 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of transcutaneous phrenic nerve stimulation on preventing diaphragm atrophy in patients requiring invasive mechanical ventilation for over 72 hours. Participants will receive electrical stimulation through the skin to contract the diaphragm muscle, with the aim of enhancing muscle function and facilitating earlier extubation. The study will evaluate diaphragm muscle condition using ultrasonography and collect various patient data during the intervention period. Conducted at a single center, the study aims to enroll a total of 80 patients over the course of one year.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are on invasive mechanical ventilation for 72 hours or more.
Not a fit: Patients under 18, those with certain medical conditions like neuromuscular diseases or severe obesity, and those requiring less than 72 hours of mechanical ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help ICU patients recover faster by preventing diaphragm atrophy and reducing the duration of mechanical ventilation.
How similar studies have performed: While the specific approach of transcutaneous phrenic nerve stimulation is novel, similar studies have shown promise in muscle preservation during mechanical ventilation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:Patients on invasive mechanical ventilation for 72 hours or more Patients older than 18 years Exclusion Criteria: Patients under 18 years of age * 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
Where this trial is running
Istanbul, Bakirkoy
- Dr.SadiKonuk EAH — Istanbul, Bakirkoy, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Safiye Tuba Kaplan
- Email: sipahituba79@gmail.com
- Phone: +9
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.