Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT02871102
Status:
TERMINATED
Last Update Posted:
2018-06-07
First Post:
2016-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stress Index to Individualize Mechanical Ventilation in ARDS
Sponsor:
Vanderbilt University
Organization:
Study Overview
Official Title:
Right-Sizing Tidal Volume in ARDS: Using the Stress Index to Optimize Mechanical Ventilation to Individual Respiratory Mechanics
Status:
TERMINATED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The ART Trial was published suggesting harm by the intervention protocol, which was closely related to the protocol in this study, so the study was terminated.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute respiratory distress syndrome (ARDS) is a widely prevalent and morbid disease for which the current standard treatment is supportive care and avoidance of complications with lung-protective ventilation. Lower-tidal volume ventilation has been largely accepted as a means of lung protective ventilation, but the mechanism for its effectiveness is not yet clear, and debate remains as to how best to choose positive end-expiratory pressure (PEEP). Reduction in driving pressure (plateau pressure minus PEEP) has been suggested as a possible means to minimize ventilator-induced lung injury. This protocol aims to identify the range of safe paired-settings of PEEP and tidal volume, with selection guided by driving pressure and the stress index, a tool to recognize potential lung hyperinflation during mechanical ventilation.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: