Status:

COMPLETED

Accuracy of Pulse Oximeters With Profound Hypoxia

Lead Sponsor:

CardiacSense Ltd.

Conditions:

SpO2

Eligibility:

All Genders

18-50 years

Phase:

NA

Brief Summary

This project aims to test the accuracy of pulse oximeters during mild, moderate, and severe hypoxia, i.e., a range of arterial HbO2 saturation from 100 down to 70%. A typical study will include at lea...

Detailed Description

After local anesthetic injection, a 22-gauge catheter is inserted in one radial artery. Pulse oximeters are attached to fingers, ears, or flat body surfaces. Subjects are in a comfortable semi-recumbe...

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\>30).
  • 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.

Key Trial Info

Start Date :

June 2 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 3 2021

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT05322382

Start Date

June 2 2021

End Date

June 3 2021

Last Update

April 18 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of California at San Francisco

San Francisco, California, United States, 94143