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NCT Number: NCT06609577

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

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.

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Key information

Conditions

Respiratory Failure Mechanical Ventilation Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location status: Recruiting

Location contact

Daishan Jiang

CONTACT

[email protected]

13773627637

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Weaning Success Rate

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

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

Secondary outcomes

  1. 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.

    The total duration of invasive mechanical ventilation, measured in hours, from the initiation of mechanical ventilation post-randomization until successful weaning, defined as 48 consecutive hours of spontaneous breathing without any invasive mechanical ventilation support.

  2. ICU Length of Stay

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

    The total number of days the patient stays in the Intensive Care Unit (ICU), from the date of ICU admission until the date of ICU discharge.

  3. 30-Day and 90-Day Survival Rates

    Time frame: Follow-up conducted at 30 days and 90 days after admission

    The survival rates of patients at 30 and 90 days after successful weaning, assessing outcomes.

  4. 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.

    Changes in diaphragm thickness and prevention of muscle atrophy, assessed by ultrasound, comparing baseline values (at randomization) with measurements taken during treatment and at follow-up intervals. Measurements will be performed at predefined time points to evaluate the impact of treatment on diaphragm preservation.

Study contacts

Contact information is provided by the study sponsor or research team.

Daishan Jiang

CONTACT

[email protected]

+8613773627637

Sponsors and collaborators

Lead sponsor

Daishan Jiang

Other

Registry information

Official study title

Personalized Ultrasound Guided Pacing of the External Diaphragm to Improve Outcomes in Patients Undergoing Invasive Mechanical Ventilation: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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