Electrical stimulation to improve diaphragm function in ICU patients
Electrical Phrenic Nerve Stimulation in Patients With Ventilator-induced Diaphragm Dysfunction: a Randomized Controlled Study
This study is testing if a new electrical treatment can help improve diaphragm function in ICU patients who have been on a ventilator for a while.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06436950 on ClinicalTrials.gov |
What this trial studies
This study examines the efficacy of transcutaneous electrical phrenic nerve stimulation (TEPNS) in patients suffering from ventilator-induced diaphragmatic dysfunction (VIDD). Patients aged 18 and older, who have been on a ventilator for at least 48 hours and have a diaphragm thickening fraction of less than 25%, will be randomly assigned to either receive TEPNS twice daily for five days or continue with usual care. The study aims to collect various clinical data to evaluate the impact of TEPNS on diaphragm function and overall patient outcomes in the intensive care unit setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been on mechanical ventilation for at least 48 hours and have a diaphragm thickening fraction of less than 25%.
Not a fit: Patients with a pacemaker, severe chronic obstructive pulmonary disease, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve diaphragm function and recovery in patients with VIDD, potentially reducing their length of stay in the ICU.
How similar studies have performed: While the approach of using electrical stimulation for diaphragm function is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged ≥ 18 years * ventilated for at least 48 h with an expected stay of more than 7 days in the ICU * diaphragm thickening fraction (DTF)\< 25% Exclusion Criteria: * having a pacemaker * cutaneous lesion that could interfere with probes * previous diaphragmatic nerve paralysis * body mass index \> 35 kg/m2 * severe chronic obstructive pulmonary disease (FEV1/FVC\<30%) * pregnancy or lactation * decision to withhold life-sustaining treatment
Where this trial is running
Beijing, Beijing Municipality
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Zongyu Wang, Dr. — Peking University Third Hospital
- Study coordinator: Zongyu Wang, Dr.
- Email: wangzy1976@126.com
- Phone: 008601082267028
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.