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

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.

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.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Monitoring; Fluid Challenge
• Intervention / Treatment: Procedure: Starting LRM (Lung Recruitment Maneuver); Procedure: Starting VtC (Tidal Volume Challenge)

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Hop Claude Huriez Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Starting LRM (Lung Recruitment Maneuver)	Procedure: Starting LRM (Lung Recruitment Maneuver); The LRM is performed first for 30 seconds (an insufflation pressure of 30 cmH2O for 30 seconds is applied). After a free interval of 3 minutes, the VtC is done during 1 minute. For VtC, tidal volume is increased from 6 to 8 ml.kg-1 of predicted body weight. Finally, after a new free interval of 3 minutes, the fluid challenge (consisting in fluid administration of 250 ml of Ringer Lactate) is started for 10 minutes (in aim to determine which patients are responders). This sequence is repeated every 30 minutes (maximum four times).
Experimental: Group 2; Starting VtC (Tidal Volume Challenge)	Procedure: Starting VtC (Tidal Volume Challenge); The VtC is performed first for 1 minute. After a free interval of 3 minutes, the LRM is done for 30 seconds. Finally, after another free interval of 3 minutes, the fluid challenge is started for 10 minutes. This sequence is repe-tead every 30 minutes (maximum four times).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
The area under the ROC (AUC) curve of VPP during the alveolar recruit-ment maneuver.	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	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 of the two techniques calculated above.	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	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 area under the ROC curve (AUC) of stroke volume variation (SVV) during the tidal volume challenge (VtC).	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	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 area under the ROC curve (AUC) of stroke volume variation (SVV) during the lung recruitment maneuver.	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	throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
Number of complications in pneumothorax	Pneumothorax is detected on chest x-ray in recovery room and then on clinical examination at Day 2.	1 day (at recovery room after surgery) and at day 2

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Actual): July 17, 2021
• Study Completion (Actual): July 17, 2021

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Tidal Volume Challenge; Lung Recruitment Maneuver; Pulse Pression Varia-tion; Stroke Volume Variation.; Fluid Responsiveness.
• Other Study ID Numbers: 2019_71; 2020-A01460-39 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No