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

Overview

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.

Detailed 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.

Interventions

• Device Diaphragm Ultrasound-Guided External Diaphragm Pacing
  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 speci

Primary outcome measures

• Weaning Success Rate [Time frame: Assessed 48 hours and 72 hours after weaning to ensure no need for reintubation or mechanical support.]

Secondary outcome measures (4)

• Total Duration of Invasive Mechanical Ventilation [Time frame: 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 [Time frame: 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 [Time frame: Follow-up conducted at 30 days and 90 days after admission]
• Prevention of Diaphragm Atrophy [Time frame: 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.]

Eligibility criteria

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 \<6 months.
• Patients who are unable to be weaned from mechanical ventilation, such as patients with severe brain injury or paraplegia.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Affiliated Hospital of Nantong University — Nantong

Identifiers

NCT: NCT06609577 · 2021-L146

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗