Comparison of PVI and RPVI

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.

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Key information

Conditions

Venous; Return (Anomaly) Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Anesthésie Réanimation, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon

Bron, 69394, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PVI and RPVI measurements

Device

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.

Primary outcomes

Evaluation of the diagnostic characteristics of RPVI in comparison to PVI

Time frame: 30 minutes

Agreement and interchangeability of RPVI and PVI: Bland Altman analysis for repeated measurements

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: RPVI

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Jun 28, 2018
Registry last updated: Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed