Accuracy of methemoglobin detection by pulse CO-oximetry during hypoxia.
John R Feiner, Philip E Bickler, Paul D Mannheimer
https://pubmed.ncbi.nlm.nih.gov/20007731Actively Recruiting
Age: 18Years - 50Years
All Genders
Healthy Volunteers
ID06142019
Pulse Oximeter Accuracy in Healthy Humans During Hypoxia
Led by University of California, San Francisco · Updated on 2025-09-02
10000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of pulse oximeters in healthy adults aged 18 to 50 during varying levels of low oxygen in the blood, called hypoxia. The study compares pulse oximeter readings taken non-invasively from fingers, ears, and other sites with a gold-standard measurement from arterial blood samples analyzed by a laboratory hemoximeter. This research helps manufacturers submit reliable data for regulatory approval of these devices. During the study, stable low oxygen levels are created by having participants breathe specially controlled air mixtures. Multiple short tests called "runs" are performed, each lasting 10-15 minutes with several steady oxygen plateaus tested per run. Up to 35 arterial blood samples may be taken per participant for comparison. Additional tests may include conditions like hyperventilation or motion to assess device accuracy under different scenarios. Participants will have blood oxygen and other factors measured repeatedly during the sessions, with pulse oximeter probes placed at various body sites. Researchers also assess skin pigmentation and finger size to understand their effects on readings. The main outcome measured is blood oxygen saturation (SpO2). The study involves close monitoring and informed consent, with total participation time depending on the number of runs and samples collected.
CONDITIONS
Brief Title
Pulse Oximeter Accuracy in Healthy Humans During Hypoxia
Who Can Participate
Age: 18Years - 50Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- The subject is male or female, aged 18 to less than 50 years
- The subject is in good general health with no evidence of medical problems
- The subject is fluent in both written and spoken English
- The subject has provided informed consent and agrees to follow study procedures
You will not qualify if you...
- The subject is obese with BMI greater than 35
- The subject has a known history of heart, lung, kidney, or liver disease
- Diagnosis of asthma, sleep apnea, or use of CPAP device
- The subject has diabetes
- The subject has a clotting disorder
- The subject has hemoglobinopathy or history of anemia making them unsuitable for study
- The subject has any other serious systemic illness
- The subject is a current smoker
- Injury, deformity, or abnormality at sensor sites interfering with sensors
- History of fainting or vasovagal response
- History of sensitivity to local anesthesia
- Diagnosis of Raynaud's disease
- Unacceptable collateral circulation based on investigator exam
- The subject is pregnant, lactating, or trying to get pregnant
- The subject is unable or unwilling to provide informed consent or comply with procedures
- Any other condition making the subject unsuitable for the study as per investigator opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo controlled desaturation by breathing hypoxic air mixtures to create stable hypoxemia while pulse oximeter readings and arterial blood samples are collected for comparison.
1 to 2 visits depending on the number of testing runs
Long-term Monitoring
Duration - Up to 1 day after testing
Participants may be observed for additional measurements including skin pigmentation and finger diameter, with possible assessments under different conditions such as motion or posture changes.
Additional assessments may occur depending on study procedures
Trial Site Locations
Total: 1 location
1
Hypoxia Lab, UCSF Department of Anesthesia and Perioperative Care
San Francisco, California, United States, 94143
Actively Recruiting
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Research Team
P
Phil Bickler, MD, PhD
M
Michael Lipnick, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Dark skin decreases the accuracy of pulse oximeters at low oxygen saturation: the effects of oximeter probe type and gender.
John R Feiner, John W Severinghaus, Philip E Bickler
https://pubmed.ncbi.nlm.nih.gov/18048893Effects of skin pigmentation on pulse oximeter accuracy at low saturation.
Philip E Bickler, John R Feiner, John W Severinghaus
https://pubmed.ncbi.nlm.nih.gov/15791098