NCT06609577 Personalized Ultrasound-Guided External Diaphragm Pacing to Improve Outcomes in Invasive Mechanically Ventilated Patients
| NCT ID | NCT06609577 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Daishan Jiang |
| Condition | Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-11-01 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to explore whether personalized external diaphragm pacing (EDP) guided by real-time diaphragm ultrasound (DU) can improve outcomes for patients on invasive mechanical ventilation. Diaphragm ultrasound will be used to assess each patient's diaphragm function and adjust the pacing intensity, creating a customized treatment plan. By using this individualized approach, the investigators hope to prevent diaphragm muscle weakening, which is a common issue during prolonged ventilation, and improve the chances of successful weaning from the ventilator. The study will also incorporate advanced diaphragm function metrics, such as diaphragm thickening fraction (DTF) and diaphragmatic rapid shallow breathing index (D-RSBI), to enhance the accuracy of treatment and improve patient recovery. This trial aims to improve overall outcomes and quality of care for patients requiring long-term mechanical ventilation.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06609577 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 95 Years, studying Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06609577 currently recruiting?
Yes, NCT06609577 is actively recruiting participants. Contact the research team at jiangdaishan@ntu.edu.cn for enrollment information.
Where is the NCT06609577 trial being conducted?
This trial is being conducted at Nantong, China.
Who is sponsoring the NCT06609577 clinical trial?
NCT06609577 is sponsored by Daishan Jiang. The trial plans to enroll 150 participants.