Non-invasive stimulation of the phrenic nerve in ARDS patients
Non-invasive Phrenic Nerve Stimulation in ARDS Patients - a Feasibility Study
This study tests if a new non-invasive method to stimulate the phrenic nerve can help improve breathing and reduce complications for adults with acute respiratory distress syndrome who are on a ventilator.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Sex | All |
| Sponsor | Southeast University, China Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06572280 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of non-invasive synchronized phrenic nerve stimulation on diaphragmatic activity in patients with acute respiratory distress syndrome (ARDS) who are undergoing mechanical ventilation. The goal is to prevent ventilator-induced lung injury and diaphragm dysfunction by promoting diaphragmatic activity, which may improve patient outcomes. The study focuses on adult ARDS patients with a short duration of intubation, aiming to explore a novel intervention that could enhance respiratory function and reduce complications associated with mechanical ventilation.
Who should consider this trial
Good fit: Ideal candidates are adult patients with ARDS who are undergoing controlled mechanical ventilation and have been intubated for less than 48 hours.
Not a fit: Patients with neurological conditions affecting motor function, phrenic nerve paralysis, or other conditions that limit diaphragm movement may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the recovery and weaning process for ARDS patients on mechanical ventilation.
How similar studies have performed: While surgically implanted phrenic nerve stimulation has shown success in neurological disorders, the effects of non-invasive stimulation in ARDS patients are still unclear and represent a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult ARDS patients undergoing controlled mechanical ventilation 2. The duration of endotracheal intubation \< 48 hrs Exclusion Criteria: 1. Neurological condition affecting motor neuron or muscle (e.g. ALS) 2. Paralysis of the phrenic nerve 3. Proven or suspected spinal cord injury 4. Conditions that limit diaphragm movement 5. Patients with Implanted cardiac support systems (pacemaker, implanted defibrillator) 6. Patients with implanted medical pumps 7. Pregnancy 8. Patients with skin lesions, infections or strictures in throat/neck area 9. Patients with metallic implants 10. Refusal to sign informed consent
Where this trial is running
Nanjing, Jiangsu
- Zhongda Hospital, School of Medicine, Southeast University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: ling liu, phD — Zhongda Hospital
- Study coordinator: ling liu, phD
- Email: 18826401594@163.com
- Phone: 15901599659
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.