Validation of RPVi as a Parameter to Predict Fluid Responsiveness

This is a prospective, nonrandomized, sequential data collection study to evaluate the ability of RPVi to predict fluid responsiveness in comparison with other dynamic parameters including stroke volume variation (SVV) and/or pulse pressure variation (PPV).

Study Overview

• Status: Terminated
• Conditions: Surgery; Anesthesia
• Intervention / Treatment: Device: Pulse CO-Oximeter sensor

• Study Type: Interventional
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older at the time of consent
• Scheduled for elective surgery requiring general anesthesia and mechanical ventilation
• Arterial line and other standard of care line placement indicated as part of the scheduled surgical procedure

Exclusion Criteria:

• Patients diagnosed with or history of heart failure, angina, pulmonary heart disease, rheumatic heart disease, cardiomyopathy, congenital heart disease, or valvular heart disease.
• Patients scheduled for or has had a liver transplant
• Patients with surgeries at or around site of sensor placement or skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of pulse-oximeter physiological parameters during the study.
• Patients with cardiac arrhythmias
• Patients with intracardiac shunts

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulse Co-Oximeter sensor; All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensors.	Device: Pulse CO-Oximeter sensor; Investigational Pulse CO-Oximeter sensor will measure hemoglobin (SpHb), Pulse Rate (PR), Perfusion Index (Pi), Methemoglobin (SpMet), Pleth Variability Index (PVi), RPVi, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of RPVi to SVV and/or PPV	To evaluate the ability of RPVi to predict fluid responsiveness in comparison with other dynamic parameters including Stroke Volume Variation (SVV) and/or Pulse Pressure Variation (PPV) using Bland Altman analysis.	approximately 2-6 hours during surgery

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2018
• Primary Completion (Actual): October 20, 2021
• Study Completion (Actual): October 20, 2021

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CANN0011

Plan for Individual participant data (IPD)

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