Personalized Ultrasound-Guided External Diaphragm Pacing to Improve Outcomes in Invasive Mechanically Ventilated Patients

NCT06609577 | Recruiting FDA Device

• 1 other identifier: 2021-L146
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Mechanical Ventilation

Keywords

External Diaphragm Pacing; Diaphragm Ultrasound; Mechanical Ventilation; Ventilator Weaning; Critical Care

Outcome Measures

Primary Outcomes (1)

• Weaning Success Rate

  The proportion of patients who are successfully weaned off mechanical ventilation for at least 48 hours without respiratory failure or reintubation.

  Assessed 48 hours and 72 hours after weaning to ensure no need for reintubation or mechanical support.

Secondary Outcomes (4)

• Total Duration of Invasive Mechanical Ventilation

  From the date of randomization until the time of successful weaning or patient discharge, whichever comes first, assessed up to 90 days after admission.

• ICU Length of Stay

  From the date of randomization until the date of ICU discharge, assessed up to 90 days after admission..

• 30-Day and 90-Day Survival Rates

  Follow-up conducted at 30 days and 90 days after admission

• Prevention of Diaphragm Atrophy

  From the date of randomization, assessed at baseline (within 24 hours post-randomization), on days 3 during treatment, and at the time of successful weaning, or until the date of patient discharge, , whichever comes first, assessed up to 90 days.

Study Arms (2)

Control group

NO INTERVENTION

Received standard mechanical ventilation withdrawal protocol without diaphragmatic external pacing

Invention group

EXPERIMENTAL

Diaphragm function was monitored by diaphragmatic ultrasound to personalize the intensity of diaphragm extracorporeal pacing.

Device: Diaphragm Ultrasound-Guided External Diaphragm Pacing

Interventions

Diaphragm Ultrasound-Guided External Diaphragm Pacing DEVICE

This intervention, Diaphragm Ultrasound-Guided External Diaphragm Pacing (DU-EDP), is distinguished by its personalized approach, where diaphragm pacing is dynamically adjusted based on real-time diaphragm function measurements obtained through bedside diaphragm ultrasound (DU). Unlike standard external diaphragm pacing (EDP) interventions that use uniform pacing parameters, DU-EDP allows for the customization of pacing intensity, frequency, and duration for each patient. This intervention specifically integrates novel diaphragm function indices, such as diaphragm thickening fraction (DTF) and diaphragmatic rapid shallow breathing index (D-RSBI), to enhance precision in weaning from mechanical ventilation. The combination of these advanced metrics with real-time ultrasound guidance makes DU-EDP a highly individualized and innovative intervention for critically ill, mechanically ventilated patients.

Invention group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years of age undergoing invasive mechanical ventilation.
• Expected duration of mechanical ventilation ≥48 hours.

You may not qualify if:

• ICU expected length of stay less than 48 hours
• severe phrenic nerve or diaphragmatic injury that is unable to respond to diaphragmatic pacing.
• Patients who have received or are scheduled to receive other respiratory assistance or diaphragmatic pacing interventions.
• Patients with end-stage disease with an expected survival of \<6 months.
• Patients who are unable to be weaned from mechanical ventilation, such as patients with severe brain injury or paraplegia.

Sponsors & Collaborators

• Daishan Jiang: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Daishan Jiang

CONTACT

+8613773627637; jiangdaishan@ntu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Attending Physician

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 24, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)