TerminatedNot Applicable

Validation of RPVi as a Parameter to Predict Fluid Responsiveness

Stopped: Sponsor requested

United States63 participantsStarted 2018-09-24

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial was terminated before completing — can you tell me why it was stopped early, and what that means for the reliability of any findings about RPVi as a way to monitor fluid levels during surgery?
2Since this study was comparing RPVi to established measurements like SVV and PPV for predicting how a patient responds to fluids during surgery, are those existing methods already being used in my care, and are they considered the current standard?
3Given that this trial is no longer recruiting and was terminated, are there other active or completed studies on fluid monitoring during anesthesia that might be more relevant to decisions about my surgery?
4How does the way fluid responsiveness is monitored during my procedure actually affect my outcomes, and is this something my anesthesia team already has a well-established approach for?
5Since this trial is listed under a non-applicable phase, meaning it wasn't testing a new drug but rather a monitoring approach, does that change how much uncertainty there is about the safety or benefit compared to what's already standard practice?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comparison of RPVi to SVV and/or PPV

Timeframe: approximately 2-6 hours during surgery

Trial details

NCT IDNCT03706430

SponsorMasimo Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-20

Results submitted2023-01-23

View on ClinicalTrials.gov More Surgery trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.