NCT03572894

Comparison of PVI and RPVI

Comparison of PVI and RPVI During a Tidal Volume Challenge Under General Anesthesia: A Prospective Validation Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Pleth Variability Index (PVI) is a non-invasive and automated measure of the respiratory variations of plethysmography during mechanical ventilation. PVI is extracted via an algorithm implemented on Masimo Radical 7 device (Masimo, Irvine, CA). PVI is commonly used in anesthesiology and has been validated to predict fluid responsiveness and optimize fluid administration in the surgical setting. However, the signal/noise ratio of PVI makes acute changes in PVI somewhat difficult to interpret at the bedside. Subsequently, a new algorithm entitled RPVI (Rainbow Pleth Variability Index), has been developed in order to improve the signal/noise ratio of PVI and facilitate its clinical use by practitioners. The details of this new proprietary built-in algorithm are unknown and no data are available to date. Therefore, the main objective of the study was to compare RPVI and PVI during dynamic changes in venous return induced by a tidal volume (Vt) challenge during mechanical ventilation in anesthetized patients. The hypothesis was that the agreement between both dynamic indices would be good.

Conditions

• Venous; Return (Anomaly)

Interventions

Type	Name	Description
DEVICE	PVI and RPVI measurements	PVI and RPVI measurements during variations of the tidal volume (Vt challenge) and a recruitment maneuver in anesthetized and mechanically ventilated patients. * T0 : Vt 6 mL/kg of predicted body weight (PBW) during 5 minutes * T1 : Vt 8 mL/Kg of PBW during 5 minutes * T2 : Vt 10 mL/kg of PBW during 5 minutes * T3 : Vt 6 mL/kg of PBW during 5 minutes * T4 : A single recruitment maneuver Data will be recorded at each step.

Timeline

• Start date: 2018-07-25
• Primary completion: 2018-09-27
• Completion: 2018-09-27
• First posted: 2018-06-28
• Last updated: 2018-12-05

Locations

1 site across 1 country: France