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Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia

NCT04446247 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2020-10-19

Study results available
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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. 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

DIAGNOSTIC_TEST

Owlet Smart Sock Sensor 3rd Generation

Pulse Oximetry

Sponsors & Collaborators

  • Owlet Baby Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Philip Bickler, MD · UCSF Department of Anesthesia

  • John Feiner, MD · UCSF Department of Anesthesia

Eligibility

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

Timeline & Regulatory

Start
2020-03-12
Primary Completion
2020-03-13
Completion
2020-03-13

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT04446247 on ClinicalTrials.gov