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Pulse Oximeter Hypoxia

Primary Purpose

Oximetry

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MyHomeDoc

About this trial

This is an interventional diagnostic trial for Oximetry focused on measuring myhomedoc, pulse oximetry, oximeter

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

The subject is obese (BMI>30).
The 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.
The subject a 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.
The subject has any other serious systemic illness.
The 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.
The subject has a history of fainting or vasovagal response.
The subject has a history of sensitivity to local anesthesia.
The subject has a diagnosis of Raynaud's disease.
The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
The subject is pregnant, lactating or trying to get pregnant.
The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Sites / Locations

Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MyHomeDoc

Arm Description

Comparison of MyHomeDoc pulse oximetry readings with arterial blood saturation laboratory analysis in the same subject

Outcomes

Primary Outcome Measures

Saturation level measurement

Induction of hypoxia by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide to allow measurement of oxyhemoglobin saturation between 70-100%. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeters readings were stable

Secondary Outcome Measures

Full Information

NCT ID

NCT04562584

First Posted

September 14, 2020

Last Updated

September 18, 2020

Sponsor

MyHomeDoc Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04562584

Brief Title

Pulse Oximeter Hypoxia

Official Title

Accuracy of Pulse Oximeters With Profound Hypoxia

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

June 3, 2020 (Actual)

Primary Completion Date

June 4, 2020 (Actual)

Study Completion Date

June 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MyHomeDoc Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this project is to test the accuracy of pulse oximeters (devices intended to measure oxygen saturation in blood noninvasively) during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample processed in a laboratory.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oximetry

Keywords

myhomedoc, pulse oximetry, oximeter

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MyHomeDoc

Arm Type

Experimental

Arm Description

Comparison of MyHomeDoc pulse oximetry readings with arterial blood saturation laboratory analysis in the same subject

Intervention Type

Device

Intervention Name(s)

MyHomeDoc

Intervention Description

MyHomeDoc device SpO2 measurements and parallel blood gas analysis to determine oxyhemoglobin saturation (SaO2) using an ABL-90 multi-wavelength oximeter.

Primary Outcome Measure Information:

Title

Saturation level measurement

Description

Time Frame

1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The subject is male or female, aged ≥18 and <50. The subject is in good general health with no evidence of any medical problems. The subject is fluent in both written and spoken English. The subject has provided informed consent and is willing to comply with the study procedures. Exclusion Criteria: The subject is obese (BMI>30). The 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. The subject a 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. The subject has any other serious systemic illness. The 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. The subject has a history of fainting or vasovagal response. The subject has a history of sensitivity to local anesthesia. The subject has a diagnosis of Raynaud's disease. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test). The subject is pregnant, lactating or trying to get pregnant. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip E Bickler, Ph.D., M.D.

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Pulse Oximeter Hypoxia

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