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Determination of SpO2 and PR Accuracy Specifications At Rest (71Ag_Vital-0031)

NCT ID: NCT05297500

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-23

Study Completion Date

2025-03-29

Brief Summary

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The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest

Detailed Description

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This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.

Conditions

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Hypoxia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult healthy subjects

Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state

Pulse oximeter

Intervention Type DEVICE

OLV-4202 pulse oximeter (SW version: 01-12)

Interventions

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Pulse oximeter

OLV-4202 pulse oximeter (SW version: 01-12)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Both male and female subjects who can give written informed consent
* Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
* Meeting the demographic requirements

Exclusion Criteria

* Pregnant women
* Significant arrhythmia
* Blood pressure above 150 systolic or 90 diastolic
* Carboxyhemoglobin levels over 3%
* Subjects whom the investigator consider ineligible for the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

Nihon Kohden

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCSF Hypoxia Research Laboratory

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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71Ag_Vital-0031

Identifier Type: -

Identifier Source: org_study_id