CompletedNot Applicable

Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI

United States50 participantsStarted 2017-03-09

Plain-language summary

The study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (SpHb) system with hemoglobin as measured by other validated devices. The study will also evaluation oxygen reserve index (ORI) to correlate with partial pressure of oxygen (PaO2), and to evaluate pleth variability index (PVI) with stroke volume variation (SVV) or pulse pressure variation (PPV) values.

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: * Admitted into the ICU * Aged 18 years or older * Mechanically ventilated * Arterial line placed * Vigileo/Flotrac System being used for guidance of fluid management Exclusion Criteria: * Pregnancy * Prisoner status * Extreme hemodynamic instability * Multiple vasopressors in use with questionable peripheral blood flow * Lack of appropriate sites for sensor placement * Patient or patient's legal representative refusal

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Noninvasive Pulse Oximetry-determined SpHb Bias

Timeframe: Duration of study participation is up to three days.

Correlation of PVI Measurement Compared With PPV or SVV

Timeframe: Duration of study participation is up to three days.

Correlation of "ORI" With Partial Pressure of Oxygen (PaO2) "PaO2" Measurement From Blood Gas Analysis

Timeframe: Duration of study participation is up to three days.

Trial details

NCT IDNCT02841397

SponsorMasimo Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-10-11

Results submitted2021-08-20

View on ClinicalTrials.gov More Surgery trials

Plain-language summary

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.

What they're measuring

Noninvasive Pulse Oximetry-determined SpHb Bias

Timeframe: Duration of study participation is up to three days.

Correlation of PVI Measurement Compared With PPV or SVV

Timeframe: Duration of study participation is up to three days.

Correlation of "ORI" With Partial Pressure of Oxygen (PaO2) "PaO2" Measurement From Blood Gas Analysis

Timeframe: Duration of study participation is up to three days.