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SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor

NCT05141500 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-12-21

Study results available
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Summary

The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors.

Conditions

Interventions

DEVICE

STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS

Reprocessed noninvasive pulse oximeters * 1859 \& 2329 * MAX-A \& MAX-N

Sponsors & Collaborators

Principal Investigators

  • Philip E Bickler, MD, PhD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2021-11-03
Completion
2021-11-03
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05141500 on ClinicalTrials.gov