An observational study in Venous; Return (Anomaly), sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-05.
Sponsored by Hospices Civils de Lyon · Observational
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.
Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All adult patients undergoing closed-chest surgery in the supine position under general anaesthesia.
Exclusion Criteria:
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.
Evaluation of the diagnostic characteristics of RPVI in comparison to PVI
Agreement and interchangeability of RPVI and PVI: Bland Altman analysis for repeated measurements
Time frame: 30 minutes
Plan to share: No
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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon