Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513299
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Effectiveness of Low Volume and Low Pressure in Severe Hypoxemic Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessing the Effectiveness of Low Tidal Volume and Low Driving Pressure in Mechanically Ventilated Severe Hypoxemic Patients a Multicenter Emulated Target Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
avengARDS
Brief Summary:
The present study set up to answer two questions a how low tidal volume must be to provide protective ventilatory settings able to minimize the risk of death due to Ventilator-Induced Lung Injury VILI b if protection from VILI is better achieved by targeting the driving pressure instead of the tidal volume what is the optimal target for the driving pressure Solving these questions is pivotal for clinicians to personalized and precise mechanical ventilation practices to reduce the risk of VILI and avoid unnecessary risks associated to protective ventilatory settings
Two multicenter emulated target trials will be performed using data collected with the Electronic Health Record MargheritaTre to investigate the effect of low tidal volumes 60 to 80 mlkg PBW vs 81 to 119 mlkg PBW and low driving pressures 100-150 cmH2O vs 151-180 cmH2O respectively Data will be used to obtain the dose-response curve of lower VT and lower P in mechanically ventilated patients with acute severe hypoxemia
Two multicenter emulated target trials will be performed using data collected with the Electronic Health Record MargheritaTre to investigate the effect of low tidal volumes 60 to 80 mlkg PBW vs 81 to 119 mlkg PBW and low driving pressures 100-150 cmH2O vs 151-180 cmH2O respectively Data will be used to obtain the dose-response curve of lower VT and lower P in mechanically ventilated patients with acute severe hypoxemia
Detailed Description:
None
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