Viewing Study NCT04535115



Ignite Creation Date: 2024-05-06 @ 3:08 PM
Last Modification Date: 2024-10-26 @ 1:43 PM
Study NCT ID: NCT04535115
Status: COMPLETED
Last Update Posted: 2023-01-26
First Post: 2020-08-26

Brief Title: Tidal Volume Challenge and Lung Recruitment Maneuver TIDALREC the Reliability of Pulse Pression Variation or Stroke Volume Variation on Fluid Responsiveness
Sponsor: University Hospital Lille
Organization: University Hospital Lille

Study Overview

Official Title: Intraoperative Hemodynamic Optimization Predictive Value to Fluid Respon-siveness of the Tidal Volume Challenge and the Lung Recruitment Maneuver by Monitoring the Variation of the Pulsed Pressure and the Variation of the Systolic Ejection Volume
Status: COMPLETED
Status Verified Date: 2023-01
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: TIDALEC
Brief Summary: In order to predict fluid responsiveness in the operating room and therefore benefit of performing fluid administration to improve patients hemodynamic status it will test two ventilation strategies the Tidal Volume Challenge VtC and the Lung Recruitment Maneuver LRM

The objective is to determine whether the variation of 2 parameters such as pulse pression variation PPV and stroke volume variation SVV during these 2 strategies allows to predict fluid responsiveness in the operating room for any heavy surgery All patients will benefit from the 2 ventilation strategies then a fluid administration called fluid challenge will be performed to discriminate the true responders and others The order of the ventilation strategies will be determined by randomization
Detailed Description: None

Study Oversight

Has Oversight DMC: None
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?: None
Secondary IDs
Secondary ID Type Domain Link
2020-A01460-39 OTHER ID-RCB numberANSM None