Personalized diaphragm pacing to improve outcomes in ventilated patients
Official title: Personalized Ultrasound Guided Pacing of the External Diaphragm to Improve Outcomes in Patients Undergoing Invasive Mechanical Ventilation: a Randomized Controlled Trial
Run by Affiliated Hospital of Nantong University · NCT06609577 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 95 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Locations | 1 site (Nantong, Jiangsu) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | May 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | October 22, 2024 |
| Trial ID | NCT06609577 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are undergoing invasive mechanical ventilation for at least 48 hours.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While personalized approaches in diaphragm pacing are innovative, similar studies have shown promise in improving outcomes for mechanically ventilated patients.
Who can join: the full rules
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 it's running
-
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Daishan Jiang
- Email: jiangdaishan@ntu.edu.cn
- Phone: +8613773627637
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.