Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609577
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Personalized Ultrasound-Guided External Diaphragm Pacing to Improve Outcomes in Invasive Mechanically Ventilated Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Personalized Ultrasound Guided Pacing of the External Diaphragm to Improve Outcomes in Patients Undergoing Invasive Mechanical Ventilation a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None