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Status:

RECRUITING

Pulse Oximeter Accuracy in Healthy Humans During Hypoxia

Lead Sponsor:

University of California, San Francisco

Conditions:

Hypoxia

Skin Pigmentation

Eligibility:

All Genders

18-50 years

Brief 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 hypo...

Detailed 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 ...

Eligibility Criteria

Inclusion

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

Exclusion

  • The subject is obese (BMI\>35).
  • The subject has a known history of heart disease, lung disease, kidney or liver disease.
  • Diagnosis of asthma, sleep apnea, or use of CPAP.
  • Subject has diabetes.
  • Subject has a clotting disorder.
  • 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.
  • The subject has any other serious systemic illness.
  • The subject is a current smoker.
  • Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
  • The subject has a history of fainting or vasovagal response.
  • The subject has a history of sensitivity to local anesthesia.
  • The subject has a diagnosis of Raynaud's disease.
  • The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
  • The subject is pregnant, lactating or trying to get pregnant.
  • The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
  • The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Key Trial Info

Start Date :

November 29 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2028

Estimated Enrollment :

10000 Patients enrolled

Trial Details

Trial ID

NCT06142019

Start Date

November 29 2021

End Date

September 1 2028

Last Update

September 2 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Hypoxia Lab, UCSF Department of Anesthesia and Perioperative Care

San Francisco, California, United States, 94143