Accuracy of Pulse Oximeters With Profound Hypoxia

Oximetry Clinical Trial

Official title:

Accuracy of Pulse Oximeters With Profound Hypoxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03710980
• Other study ID #: BEDD01
• Status: Completed
• Start date: September 18, 2018
• Est. completion date: September 19, 2018

Study information

• Verified date: October 2018
• Source: Hancock Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study to assess the oxygen saturation accuracy of the Beddr SleepTuner in profound hypoxia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 19, 2018
• Est. primary completion date: September 19, 2018
• 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 bloodsample, 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.

Related Conditions & MeSH terms

• Hypoxia
• Oximetry

Intervention

Device:
• Oximeter
Participants breathe a controlled gas mixture to induce several reduced oxygen states while oximeter measurements are taken for comparison to corresponding arterial blood draw samples to assess oximeter accuracy.

Locations

Country	Name	City	State
United States	UCSF Hypoxia Lab	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Hancock Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpO2 Accuracy	Collect and analyze data to determine SpO2 accuracy of oximeters under test.	60 minutes