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

Daishan Jiang

Status

Enrolling

Conditions

Respiratory Failure

Mechanical Ventilation

Treatments

Device: Diaphragm Ultrasound-Guided External Diaphragm Pacing

Study type

Interventional

Funder types

Other

Identifiers

NCT06609577

2021-L146

Details and patient eligibility

About

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.

Full description

This study investigates the efficacy of a personalized external diaphragm pacing (EDP) protocol, dynamically guided by diaphragm ultrasound (DU), in improving outcomes in mechanically ventilated patients. Unlike traditional EDP systems that use uniform pacing parameters, this study introduces an individualized approach that uses diaphragm function-monitored by real-time DU-to adjust pacing intensity, frequency, and duration for each patient. The goal is to optimize diaphragm activity, prevent muscle atrophy, and increase the likelihood of successful weaning from mechanical ventilation.

Key innovations in this study include the integration of novel diaphragmatic performance indicators such as diaphragmatic thickening fraction (DTF) and diaphragmatic rapid shallow breathing index (D-RSBI). These parameters will be used to assess diaphragm function more accurately than conventional methods and to inform adjustments to the stimulation regimen. By targeting ventilator-induced diaphragm dysfunction (VIDD) and preventing muscle weakness, this personalized approach aims to improve clinical outcomes, reduce ventilation time and facilitate recovery in critically ill patients.

The study will be a randomized controlled design comparing the effectiveness of personalized ultrasound-guided EDP to standard mechanical ventilation weaning protocols. Participants will be critically ill, mechanically ventilated patients requiring long-term respiratory support. Outcomes will include weaning success rate, time on mechanical ventilation, and overall patient survival and recovery rates. The trial aims to advance critical care protocols by integrating personalized technology to improve patient outcomes in the mechanical ventilation setting.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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 &amp;amp;amp;lt;6 months.
Patients who are unable to be weaned from mechanical ventilation, such as patients with severe brain injury or paraplegia.