CompletedNot Applicable

OM2 Low Saturation Verification

United States28 participantsStarted 2024-11-18

Plain-language summary

The verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations.

Who can participate

Age range

18 Years – 39 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

. Healthy volunteers 18 to ≤39 years
. Subject is willing and able to comply with study procedures and duration
. Subject is willing to sign an informed consent
. Subject weighs \>40kg
. Subject is a non-smoker or has not smoked within 2 days prior to the study
. Cleared same day health assessment form and health screening

Exclusion criteria

. Subject is considered as being morbidly obese (defined as BMI \>39.5)
. Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the sites utilized)
. Subjects of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study
. Subjects with known concurrent, active respiratory conditions such as:

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

Verification of Saturation Accuracy

Timeframe: 2.5 hours

Acceptance criteria for SpO2 accuracy across the saturation range of 70-100%:

Timeframe: 2.5 hours

Acceptance criteria for pulse rate accuracy within 20-250 BPM

Timeframe: 2.5 hours

Trial details

NCT IDNCT06661889

SponsorMedtronic - MITG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-02-27

View on ClinicalTrials.gov More Hypoxia trials

Who can participate

Age range

18 Years – 39 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

. Healthy volunteers 18 to ≤39 years
. Subject is willing and able to comply with study procedures and duration
. Subject is willing to sign an informed consent
. Subject weighs \>40kg
. Subject is a non-smoker or has not smoked within 2 days prior to the study
. Cleared same day health assessment form and health screening

Exclusion criteria

. Subject is considered as being morbidly obese (defined as BMI \>39.5)
. Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the sites utilized)
. Subjects of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study
. Subjects with known concurrent, active respiratory conditions such as: