Comparison of PVI and RPVI

NCT03572894 | Completed

• 1 other identifier: 69HCL18_0313
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous; Return (Anomaly)

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69394, France

Location

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 28, 2018
• Study Start: July 25, 2018
• Primary Completion: September 27, 2018
• Study Completion: September 27, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)