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Accuracy of BabySat V3 With Profound Hypoxia and Motion

NCT05581394 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2022-10-14

No results posted yet for this study

Summary

Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained and during different motion scenarios. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.

Conditions

Interventions

DEVICE

BabySat V3

Evaluation of Accuracy of BabySat V3

Sponsors & Collaborators

Principal Investigators

  • John Feiner, MD · University of California, San Francisco

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-14
Primary Completion
2022-07-15
Completion
2022-07-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05581394 on ClinicalTrials.gov