Pulse Oximeter Accuracy in Healthy Humans During Hypoxia

Hypoxia Clinical Trial

Official title:

Pulse Oximeter Accuracy in Healthy Humans During Hypoxia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142019
• Other study ID #: 21-35637
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: February 2024
• Source: University of California, San Francisco
• Contact: Phil Bickler, MD, PhD
• Phone: 415-476-1411
• Email: Philip.bickler[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxygen. This study will be done on healthy male or females between the age group of 18-50.

Description:

This study is to determine the accuracy of pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other parts of the body, without requiring blood sampling. The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin saturation (arterial blood sample processed in a laboratory hemoximeter).The data obtained is submitted by pulse oximeter manufacturers to the FDA for device approval. Studies normally involve 10-14 normal adult volunteer paid subjects, with 20-25 1-2 ml arterial blood samples from each subject obtained at different steady-state levels of hypoxia from 70-100%. Blood samples obtained from an arterial line are measured in a hemoximeter to determine true saturation value. Some sponsors may not require any blood sampling. Some sponsors may require additional blood samples, up to 35 samples may be drawn. Readings from the test pulse oximeters are recorded and compared to these "gold-standard" blood values. The pulse oximeter probes may be located at a variety of sites on the subjects, including fingers, toes, ears, forehead, scalp and bridge of the nose. These detector-probes are all non-invasive. The level of hypoxia is measured and controlled by the investigator. A computer program that displays a prediction, breath by breath, the arterial oxygen saturation, (SaO2) of the study subject. SaO2 is computed from end-expired Po2 and Pco2 as determined by mass spectrometer gas analysis. This information permits the inspired gas mixture of air, plus CO2 and nitrogen, to be adjusted by an operator watching the value computed after each expiration on an analog meter. This computer-estimated saturation is adjusted by the operator to one of 6 levels of predicted saturation, and is held stable for about 30 seconds at each level. Two or three "runs" are conducted per subject. Each "run" lasts 10-15 min and 4 to 5 plateaus are tested per run. The manufacturer may choose the target values. Plateaus are typically sought at 96%, 87%, 77%, 92%, 82% and 72%. Other manufacturers have asked for an equal number of data points but with all points between 70% and 100%. Some sponsors may also request additional variables to be measured during testing including high or low CO2, where subjects will be asked to hyperventilate; low perfusion, where subjects will be asked to lay flat, or with their head up or down; testing pulse oximeters during motion, or with the subject's hand fixed to a motion machine. The subject's will be informed by the study staff and in the consent form if any of these additional procedures apply.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

1. The subject is male or female, aged =21 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>30).

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.

Related Conditions & MeSH terms

• Hypoxia
• Skin Pigmentation

Intervention

Device:
• Controlled desaturation (hypoxemia)
Stable hypoxemia is created in healthy subjects by having them breathe hypoxic air mixtures

Locations

Country	Name	City	State
United States	Hypoxia Lab, UCSF Department of Anesthesia and Perioperative Care	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bickler PE, Feiner JR, Severinghaus JW. Effects of skin pigmentation on pulse oximeter accuracy at low saturation. Anesthesiology. 2005 Apr;102(4):715-9. doi: 10.1097/00000542-200504000-00004. — View Citation

Feiner JR, Bickler PE, Mannheimer PD. Accuracy of methemoglobin detection by pulse CO-oximetry during hypoxia. Anesth Analg. 2010 Jul;111(1):143-8. doi: 10.1213/ANE.0b013e3181c91bb6. Epub 2009 Dec 10. — View Citation

Feiner JR, Severinghaus JW, Bickler PE. Dark skin decreases the accuracy of pulse oximeters at low oxygen saturation: the effects of oximeter probe type and gender. Anesth Analg. 2007 Dec;105(6 Suppl):S18-S23. doi: 10.1213/01.ane.0000285988.35174.d9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpO2	Reading on pulse oximeter device which is an estimate of the patient's blood oxygen level.	08/01/2025
Secondary	Blood gas SO2	Arterial blood gas sample results showing exact SpO2 levels. SpO2 ranges from 1% to 100%. Our target SpO2 levels are between 67% and 100%.	08/01/2025
Secondary	Skin Pigmentation by ITA	ITA stands for individual typology angle from a spectrophotometer which is an objective measurement of skin pigmentation. The categories for the ITA scale are the following: > 55 Very Light, 41 to 55 Light, 28 to 41 Intermediate, 10 to 28 Tan, -30 to 10 Brown, < -30 Dark.	08/01/2025
Secondary	Finger Diameter	Finger diameter is measured to ensure that the pulse oximeters being tested work with a variety of finger sizes. Finger diameter is measured in mm.	08/01/2025
Secondary	Skin Pigmentation by Monk Scale	The Monk scale is a subjective categorization of skin pigmentation. The Monk Scale is a 10 shade scale designed to to be easy-to-use for development and evaluation of technology while presenting a more representative range of skin tones than other common qualitative scales. The Monk Scale is from A to J. A being the lightest skin color and J the darkest.	08/01/2025