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.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Fluid Challenge
- Sponsor
- University Hospital, Lille
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- The area under the ROC curve (AUC) of the variation of the pulsed pressure (VPP) during the tidal volume challenge (VtC).
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
The area under the ROC curve (AUC) of the variation of the pulsed pressure (VPP) during the tidal volume challenge (VtC).
Time Frame: 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
- 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 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)
- Number of complications in pneumothorax(1 day (at recovery room after surgery) and 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 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)