Comparison of PVI and RPVI

Completed

• Conditions: Venous; Return (Anomaly)

• Registration Number: NCT03572894
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-28
• Study Start: 2018-07-25
• Primary Completion: 2018-09-27
• Study Completion: 2018-09-27
• Last Update Submitted: 2018-12-04
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Age > 18
• Low or intermediate risk surgery or noninvasive procedures in the supine position
• General anaesthesia and volume-controlled mechanical ventilation.

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Exclusion Criteria

• Non sinus heart rhythm
• Left Ventricular Ejection Fraction < 50%
• Documented right ventricle failure
• Lack of patient consent
• Pregnancy
• Minor patient or under tutorship
• Presence of spontaneous ventilatory movements (attested by a real respiratory rate higher than the set respiratory rate)
• Report HR / RR <3.6 (HR: heart rate, RR: respiratory rate)
• Open chest surgery
• Laparoscopic surgery
• Vital or lateral decubitus surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the diagnostic characteristics of RPVI in comparison to PVI	30 minutes	Agreement and interchangeability of RPVI and PVI: Bland Altman analysis for repeated measurements

Trial Locations

Locations (1)

Service d'Anesthésie Réanimation, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon; 🇫🇷 Bron, France