Accuracy of Pulse Oximeters With Profound Hypoxia

NCT ID: NCT05322382

Last Updated: 2022-04-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-02

Study Completion Date

2021-06-03

Brief Summary

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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 least ten subjects (at least 200 necessary data points to meet the ISO 80601-2-61:2017).

Detailed Description

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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-recumbent position. Subjects then breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia. Stable, safe, and controlled hypoxia is breath-by-breath by breath respiratory gas analysis and a computer program that permits the inspired gas mixture to be adjusted to achieve a level of lung alveolar gas that will achieve the desired degree of saturation.

Conditions

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SpO2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single

Subjects undergo an interventional procedure and non-invasive measurements of SpO2.

Group Type EXPERIMENTAL

A-line

Intervention Type PROCEDURE

Subjects breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia.

Interventions

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A-line

Subjects breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia.

Intervention Type PROCEDURE

Other Intervention Names

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Hypoxemia

Eligibility Criteria

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Inclusion Criteria

1. The subject is male or female, aged ≥18 and \<50.
2. The subject is in good general health with no evidence of any medical problems.
3. The subject is fluent in both written and spoken English.
4. The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria

1. The subject is obese (BMI\>30).
2. The subject has a known history of heart disease, lung disease, kidney or liver disease.
3. Diagnosis of asthma, sleep apnea, or use of CPAP.
4. Subject has diabetes.
5. Subject has a clotting disorder.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CardiacSense Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Bickler, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF Hypoxia Lab

Locations

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University of California at San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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008_SPO_CV_OS_USF

Identifier Type: -

Identifier Source: org_study_id

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