Pulse Oximeter Accuracy in Healthy Humans During Hypoxia
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.
Conditions:
🦠 Hypoxia 🦠 Skin Pigmentation
🗓️ Study Start (Actual) 1 March 2024
🗓️ Primary Completion (Estimated) 1 August 2025
✅ Study Completion (Estimated) 1 August 2025
👥 Enrollment (Estimated) 10000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 San Francisco, California, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 21 Years to 50 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 September 2023
  • First Submitted that Met QC Criteria 15 November 2023
  • First Posted 21 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 February 2024
  • Last Update Posted 29 February 2024
  • Last Verified February 2024