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Validation of RPVi as a Parameter to Predict Fluid Responsiveness

NCT ID: NCT03706430

Last Updated: 2025-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-24

Study Completion Date

2021-10-20

Brief Summary

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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).

Detailed Description

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Conditions

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Surgery Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Pulse Co-Oximeter sensor

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

Group Type EXPERIMENTAL

Pulse CO-Oximeter sensor

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Masimo Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CANN0011

Identifier Type: -

Identifier Source: org_study_id