Trial Outcomes & Findings for Validation of RPVi as a Parameter to Predict Fluid Responsiveness (NCT NCT03706430)

Last Updated: 2025-11-13

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

63 participants

Primary outcome timeframe

approximately 2-6 hours during surgery

Results posted on

2025-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	Pulse Co-Oximeter Sensor All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensors. 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.
Overall Study STARTED	63
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Pulse Co-Oximeter Sensor All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensors. 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.
Overall Study No A-Line placed	5
Overall Study Subject had gel nail polish	1
Overall Study Nail length causing difficulties with sensor	1
Overall Study Cancelled Case	6
Overall Study Physician Decision	2

Baseline Characteristics

Validation of RPVi as a Parameter to Predict Fluid Responsiveness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pulse Co-Oximeter Sensor n=48 Participants All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensors. 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.
Age, Customized ≤ 18 years	0 Participants n=10 Participants
Age, Customized Between 18 and 65 years	23 Participants n=10 Participants
Age, Customized ≥ 65 years	25 Participants n=10 Participants
Sex: Female, Male Female	15 Participants n=10 Participants
Sex: Female, Male Male	33 Participants n=10 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants n=10 Participants
Race/Ethnicity, Customized Asian	4 Participants n=10 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=10 Participants
Race/Ethnicity, Customized White	38 Participants n=10 Participants
Race/Ethnicity, Customized Unknown or Not Reported	5 Participants n=10 Participants

PRIMARY outcome

Timeframe: approximately 2-6 hours during surgery

Population: Zero subjects were collected for validation as the study was terminated in the data collection phase due to slow enrollment

Outcome measures

Outcome data not reported

Adverse Events

Pulse Co-Oximeter Sensor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. William C. Wilson, CMO, SVP

Masimo

Phone: 949-297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place