Tidal Volume Challenge and Lung Recruitment Maneuver (TIDALREC): the Reliability of Pulse Pression Variation or Stroke Volume Variation on Fluid Responsiveness.

Not Applicable

Completed

• Conditions: Hemodynamic Monitoring; Fluid Challenge
• Interventions: Procedure: Starting LRM (Lung Recruitment Maneuver); Procedure: Starting VtC (Tidal Volume Challenge)

• Registration Number: NCT04535115
• Lead Sponsor: University Hospital, Lille

Brief Summary

In order to predict fluid responsiveness in the operating room and therefore benefit of performing fluid administration to improve patient's 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

Not available

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-31
• Study First Posted: 2020-09-01
• Study Start: 2020-11-15
• Primary Completion: 2021-07-17
• Study Completion: 2021-07-17
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patients scheduled for major abdominal, vascular or neurosurgery requiring invasive arterial monitoring of SVV and PPV with placement of a radial arterial catheter connected to the ProAQT® System.
• Block duration > 2 hours.

Exclusion Criteria

• open surgery
• history of supra ventricular arrhythmias
• beta-blocking patient
• BMI>30 kg.m-2 or <15 kg.min-2
• right ventricular dysfunction
• severe valvulopathies
• intracardiac shunt
• renal failure dialysis
• patient's refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Starting LRM (Lung Recruitment Maneuver)	Starting LRM (Lung Recruitment Maneuver)
Group 2	Starting VtC (Tidal Volume Challenge)	Starting VtC (Tidal Volume Challenge)

Primary Outcome Measures

Name	Time	Method
The area under the ROC curve (AUC) of the variation of the pulsed pressure (VPP) during the tidal volume challenge (VtC).	throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery

Secondary Outcome Measures

Name	Time	Method
The area under the ROC (AUC) curve of VPP during the alveolar recruit-ment maneuver.	throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery	The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute
The AUCs of the two techniques calculated above.	throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery	The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute
Number of complications in pneumothorax	1 day (at recovery room after surgery) and at day 2	Pneumothorax is detected on chest x-ray in recovery room and then on clinical examination at Day 2.
The area under the ROC curve (AUC) of stroke volume variation (SVV) during the tidal volume challenge (VtC).	throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery	The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute
The area under the ROC curve (AUC) of stroke volume variation (SVV) during the lung recruitment maneuver.	throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery	The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute

Trial Locations

Locations (1)

Hop Claude Huriez Chu Lille; 🇫🇷 Lille, France