Validation of RPVi as a Parameter to Predict Fluid Responsiveness

NCT03706430 | Terminated Results

• 1 other identifier: CANN0011
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Surgery; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Pulse Co-Oximeter sensor

EXPERIMENTAL

All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensors.

Device: Pulse CO-Oximeter sensor

Interventions

Pulse CO-Oximeter sensor DEVICE

Investigational Pulse CO-Oximeter sensor will measure hemoglobin (SpHb), Pulse Rate (PR), Perfusion Index (Pi), Methemoglobin (SpMet), Pleth Variability Index (PVi), RPVi, etc.

Pulse Co-Oximeter sensor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Results Point of Contact

• Title: Dr. William C. Wilson, CMO, SVP
• Organization: Masimo

william.wilson@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: September 24, 2018
• Primary Completion: October 20, 2021
• Study Completion: October 20, 2021
• Last Updated: November 13, 2025
• Results First Posted: June 22, 2023

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)