Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-02-25 @ 5:45 PM
Study NCT ID:
NCT03108118
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2017-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diaphragm Injury and Dysfunction During Mechanical Ventilation
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Diaphragm Injury and Dysfunction During Mechanical Ventilation
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MYOTRAUMA
Brief Summary:
This study is designed to evaluate the relationship between diaphragm activity during mechanical ventilation and the development of ventilator-induced diaphragm dysfunction (VIDD). Diaphragm structure, activity, and function are monitored longitudinally over the first 7 days of mechanical ventilation.
Detailed Description:
Multiple factors are responsible for injury to the diaphragm during mechanical ventilation and critical illness. Suppression of respiratory drive and respiratory muscle activity can contribute to diaphragm dysfunction and increase the risk of prolonged mechanical ventilation.
The objective of this study is to determine whether diaphragm inactivity or injurious loading of hte diaphragm during mechanical ventilation leads to the development of diaphragm weakness. To address this question, we are monitoring the diaphragm longitudinally over the first week of mechanical ventilation.
Diaphragm activity is monitored by measurements of transdiaphragmatic pressure and diaphragm electrical activity. Diaphragm function is assessed by maximal transdiaphragmatic pressure generation and by measurements of diaphragm neuromuscular coupling. Diaphragm structure is assessed by daily ultrasound imaging.
Study measurments commence at enrolment (within 36 hours of intubation) and continue for the first 7 days of the study (or until extubation or death, if earlier).
The objective of this study is to determine whether diaphragm inactivity or injurious loading of hte diaphragm during mechanical ventilation leads to the development of diaphragm weakness. To address this question, we are monitoring the diaphragm longitudinally over the first week of mechanical ventilation.
Diaphragm activity is monitored by measurements of transdiaphragmatic pressure and diaphragm electrical activity. Diaphragm function is assessed by maximal transdiaphragmatic pressure generation and by measurements of diaphragm neuromuscular coupling. Diaphragm structure is assessed by daily ultrasound imaging.
Study measurments commence at enrolment (within 36 hours of intubation) and continue for the first 7 days of the study (or until extubation or death, if earlier).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: