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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04562584
Other study ID # VVD-MHD-155
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 3, 2020
Est. completion date June 4, 2020

Study information

Verified date September 2020
Source MyHomeDoc Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date June 4, 2020
Est. primary completion date June 4, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

6. 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.

7. The subject has any other serious systemic illness.

8. The subject is a current smoker.

9. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.

10. The subject has a history of fainting or vasovagal response.

11. The subject has a history of sensitivity to local anesthesia.

12. The subject has a diagnosis of Raynaud's disease.

13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).

14. The subject is pregnant, lactating or trying to get pregnant.

15. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.

16. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
MyHomeDoc Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 hour
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