Testing pulse oximeter accuracy during low oxygen levels

Pulse Oximeter Accuracy in Healthy Humans During Hypoxia

This study tests how accurately pulse oximeters measure blood oxygen levels in healthy adults when their oxygen levels drop to different low points.

Quick facts

• Study type: Observational
• Enrollment: 10000 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06142019 on ClinicalTrials.gov

What this trial studies

This project aims to evaluate the accuracy of pulse oximeters in measuring blood oxygen levels during varying degrees of hypoxia in healthy adults. Participants will undergo controlled desaturation to create mild, moderate, and severe hypoxia, with their pulse oximeter readings compared to gold-standard arterial blood samples. The study will involve healthy males and females aged 21 to 50, and will utilize non-invasive probes placed on different body sites to gather data. The findings will contribute to the validation of pulse oximeter devices for clinical use.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 21 to 50 with no significant medical history.

Not a fit: Patients with obesity, chronic diseases, or other serious health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the reliability of pulse oximeters, leading to better monitoring of patients with respiratory conditions.

How similar studies have performed: Previous studies have shown varying results regarding pulse oximeter accuracy, making this investigation both relevant and necessary.

Eligibility criteria

Inclusion Criteria:

1. The subject is male or female, aged ≥18 and \<50.
2. The subject is in good general health with no evidence of any medical problems.
3. The subject is fluent in both written and spoken English.
4. The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

1. The subject is obese (BMI\>35).
2. The subject has a known history of heart disease, lung disease, kidney or liver disease.
3. Diagnosis of asthma, sleep apnea, or use of CPAP.
4. Subject has diabetes.
5. Subject has a clotting disorder.
6. The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
7. The subject has any other serious systemic illness.
8. The subject is a current smoker.
9. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
10. The subject has a history of fainting or vasovagal response.
11. The subject has a history of sensitivity to local anesthesia.
12. The subject has a diagnosis of Raynaud's disease.
13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
14. The subject is pregnant, lactating or trying to get pregnant.
15. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
16. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Where this trial is running

San Francisco, California

• Hypoxia Lab, UCSF Department of Anesthesia and Perioperative Care — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Philip E Bickler, MD, PhD — University of California at San Francisco
• Study coordinator: Phil Bickler, MD, PhD

Conditions Hypoxia; Skin Pigmentation