Clinical trial NCT04535115: Tidal Volume Challenge and Lung Recruitment Maneuver (TIDALREC): the Reliability of Pulse Pression Variation or Stroke Volume Variation on Fluid Responsiveness.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Challenge
Hemodynamic Monitoring
Keywords: Tidal Volume Challenge
Lung Recruitment Maneuver
Pulse Pression Varia-tion
Stroke Volume Variation.
Fluid Responsiveness.
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: The area under the ROC curve (AUC) of the variation of the pulsed pressure (VPP) during the tidal volume challenge (VtC).
timeFrame: 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 outcomes:
measure: The area under the ROC (AUC) curve of VPP during the alveolar recruit-ment maneuver.
timeFrame: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
measure: The AUCs of the two techniques calculated above.
timeFrame: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
measure: The area under the ROC curve (AUC) of stroke volume variation (SVV) during the tidal volume challenge (VtC).
timeFrame: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
measure: The area under the ROC curve (AUC) of stroke volume variation (SVV) during the lung recruitment maneuver.
timeFrame: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
measure: Number of complications in pneumothorax
timeFrame: 1 day (at recovery room after surgery) and at day 2
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Gilles Lebuffe, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: