TerminatedNot Applicable

Alternate Methodology of Pulse Oximeter Validation

Stopped: Limited staff availability

United States2 participantsStarted 2018-09-26

Plain-language summary

This study will determine if the replacement of the measured arterial blood oxygen saturation with expired (end-tidal) oxygen value is an acceptable method to calculate the accuracy of pulse oximeters.

Who can participate

Age range

18 Years – 50 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: * Aged 18 - 50 years * Subject is willing to provide written informed consent and is able to comply with anticipated study procedures Exclusion Criteria: * Body Mass Index (BMI) \< 18.0 or \> 30.0 * Known significant respiratory, cardiovascular or medical condition that precludes study participation as judged by investigator * Anemia \[hemoglobin value below lower range of normal for gender\] * Abnormal hemoglobin electrophoresis result * Exposure to nicotine \[positive test at screening or study day\] * Abnormal drug screen \[positive test at screening or on day of study\] * Positive pregnancy test for females \[serum test at screening; urine test on study day\] * Abnormal Allen's test for collateral circulation * Abnormal Electrocardiogram * Abnormal Pulmonary Function Test * Abnormal venous blood gas result * Intolerance of facemask

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

Accuracy of FDA-approved Pulse Oximeter When Calculated With RespirAct-derived End-tidal PAO2 Values

Timeframe: 1 study day

Accuracy of FDA-approved Pulse Oximeter When Calculated With Co-oximeter Measured Arterial PaO2 Values

Timeframe: 1 study day

PAO2 Values

Timeframe: 1 study day

Trial details

NCT IDNCT03628560

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-02

Results submitted2026-04-09

View on ClinicalTrials.gov More Hypoxemia trials

Who can participate

Age range

18 Years – 50 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.