Comparison of PVI and RPVI

Venous; Return (Anomaly) Clinical Trial

— RPVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03572894
• Other study ID #: 69HCL18_0313
• Status: Completed
• Start date: July 25, 2018
• Est. completion date: September 27, 2018

Study information

• Verified date: June 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 27, 2018
• Est. primary completion date: September 27, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Venous; Return (Anomaly)

Intervention

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.

Locations

Country	Name	City	State
France	Service d'Anesthésie Réanimation, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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