Comparison of PVI and RPVI (RPVI)

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

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.

Study Overview

• Status: Completed
• Conditions: Venous; Return (Anomaly)
• Intervention / Treatment: Device: PVI and RPVI measurements

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• France
  • Bron, France, 69394
    • Service d'Anesthésie Réanimation, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients undergoing closed-chest surgery in the supine position under general anaesthesia.

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the diagnostic characteristics of RPVI in comparison to PVI	Agreement and interchangeability of RPVI and PVI: Bland Altman analysis for repeated measurements	30 minutes

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2018
• Primary Completion (Actual): September 27, 2018
• Study Completion (Actual): September 27, 2018

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL18_0313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No