Clinical trial Recruiting at 1 site Interventional Ages 18 to 95

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 typeInterventional
Ages18 Years to 95 Years
SexAll
Enrollment150 (estimated)
SponsorAffiliated Hospital of Nantong University
Academic / other
Locations1 site (Nantong, Jiangsu)
StatusRecruiting
StartedNovember 1, 2024
Main results expectedMay 31, 2027
Study endsAugust 31, 2027
Registry record updatedOctober 22, 2024
Trial IDNCT06609577 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.