Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

NCT ID: NCT06460246

Last Updated: 2024-08-23

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

2024-06-25

Study Completion Date

2024-07-31

Brief Summary

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This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%.

Detailed Description

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This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%. This is done by comparing the pulse oximeter reading during brief, steady state hypoxia plateaus with a gold-standard measurement of blood oxyhaemoglobin saturation.

Conditions

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Healthy

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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Pulse Oximeter

The subjects will have a 22-gauge catheter inserted in the radial artery to measure the oxygen saturation of arterial blood and also wear pulse oximeters.

Group Type EXPERIMENTAL

Pulse Oximeter

Intervention Type DEVICE

The subjects will have a 22-gauge catheter inserted in the radial artery to measure the oxygen saturation of arterial blood and also wear pulse oximeters.

Interventions

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Pulse Oximeter

The subjects will have a 22-gauge catheter inserted in the radial artery to measure the oxygen saturation of arterial blood and also wear pulse oximeters.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged \>= 18 and \< 50.
* Subject in good general health with no evidence of any medical problems.
* Subject is fluent in both written and spoken English.
* Subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria

* Subject is obese (BMI \> 35).
* Subject has a known history of heart disease, lung disease, kidney, or liver disease.
* Diagnosis of asthma, sleep apnea, or use of CPAP.
* Subject has diabetes.
* Subject has a clotting disorder.
* Subject has hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
* Subject has any other serious systemic illness.
* Subject is a current smoker.
* Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
* Subject has a history of fainting or vasovagal response.
* Subject has a history of sensitivity to local anesthesia.
* Subject has a diagnosis of Raynaud's disease.
* Subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
* Subject is pregnant, lactating, or trying to get pregnant.
* Subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
* Subject has any other condition, which in the opinion of the investigators would make them unsuitable 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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Acurable Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vital Signs Research Group, L.L.C.

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00077383

Identifier Type: -

Identifier Source: org_study_id

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