SpO2 Validation Study - All.Health Algo Oximeter Software

Completed

Conditions studied: Device Performance, Healthy Adult Volunteers

In brief

The clinical use of pulse oximeters has reduced the frequency and necessity of invasive arterial blood sampling and has helped to improve patient safety by providing continuous information to clinicians about patients' oxygenation status. all.health is dedicated to developing and applying innovative electronic medical solutions that improve patient care with the Algo Oximeter Software, to be used in applications for monitoring oxygen saturation.

Key facts

Study ID

NCT07527000

Run by

All Health, Inc.

People needed

25

Starts

2026-04-27

Expected to finish

2026-05-07

Last updated by the study team

2026-05-12

Who can join

Age: 22 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participant must have the ability to understand and provide written informed consent.
• Participant is adult 22-50 years of age.
• Participant must be willing and able to comply with study procedures and duration.
• Participant is a non-smoker or who has not smoked within 2 days prior to the study.
• Male or female of any race.

You may not qualify if…

• Participant has a resting SpO2 < 92% as assessed by a pulse oximeter
• Participant is considered as being morbidly obese (defined as BMI >39.5)
• Compromised circulation (i.e., Raynaud's Syndrome), injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Tattoos in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
• Females who are pregnant
• Females who are trying to get pregnant with confirmation of positive urine pregnancy test
• Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow)
• Participants with known respiratory conditions such as: (self-reported)
• uncontrolled / severe asthma,
• flu,
• pneumonia / bronchitis,
• shortness of breath / respiratory distress,
• unresolved respiratory or lung surgery,
• emphysema, COPD, lung disease
• Recent COVID with hospitalization
• Participants with self-reported heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)
• high blood pressure: systolic >140 mmHg or diastolic >90 mmHg on 3 consecutive readings (reviewed during health screen)
• have had cardiovascular surgery, except successful minor surgery without clinical symptoms (i.e., PFO, PDA)
• chest pain (angina)
• heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
• previous heart attack
• blocked artery
• unexplained shortness of breath
• congestive heart failure (CHF)
• history of stroke
• transient ischemic attack

Where it is running

• Element Materials Technology — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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