Personalized diaphragm pacing to improve outcomes in ventilated patients
Personalized Ultrasound Guided Pacing of the External Diaphragm to Improve Outcomes in Patients Undergoing Invasive Mechanical Ventilation: a Randomized Controlled Trial
This study is testing if a personalized diaphragm pacing treatment can help critically ill patients on ventilators recover better and get off the machines more easily.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Locations | 1 site (Nantong, Jiangsu) |
| Trial ID | NCT06609577 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of personalized external diaphragm pacing (EDP) guided by real-time diaphragm ultrasound in improving outcomes for patients on invasive mechanical ventilation. By assessing diaphragm function and adjusting pacing parameters for each patient, the study aims to prevent diaphragm muscle weakening and enhance the chances of successful weaning from the ventilator. Key metrics such as diaphragm thickening fraction and rapid shallow breathing index will be utilized to optimize treatment. The trial will compare personalized EDP with standard weaning protocols in critically ill patients requiring long-term respiratory support.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing invasive mechanical ventilation for at least 48 hours.
Not a fit: Patients with severe phrenic nerve injury, end-stage disease, or those unable to be weaned from mechanical ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery and weaning outcomes for patients on mechanical ventilation.
How similar studies have performed: While personalized approaches in diaphragm pacing are innovative, similar studies have shown promise in improving outcomes for mechanically ventilated patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults ≥18 years of age undergoing invasive mechanical ventilation. 2. Expected duration of mechanical ventilation ≥48 hours. Exclusion Criteria: 1. ICU expected length of stay less than 48 hours 2. severe phrenic nerve or diaphragmatic injury that is unable to respond to diaphragmatic pacing. 3. Patients who have received or are scheduled to receive other respiratory assistance or diaphragmatic pacing interventions. 4. Patients with end-stage disease with an expected survival of \<6 months. 5. Patients who are unable to be weaned from mechanical ventilation, such as patients with severe brain injury or paraplegia.
Where this trial is running
Nantong, Jiangsu
- Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Daishan Jiang
- Email: jiangdaishan@ntu.edu.cn
- Phone: +8613773627637
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.