Accuracy of Pulse Oximeters With Profound Hypoxia

Completed

• Conditions: Oximetry
• Interventions: Device: Oximeter

• Registration Number: NCT03710980
• Lead Sponsor: Hancock Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-18
• Primary Completion: 2018-09-19
• Study Completion: 2018-09-19
• Status Verified: 2018-10
• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-10-16
• Last Update Submitted: 2018-10-16
• Study First Posted: 2018-10-18
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Adult Volunteer	Oximeter	-

Primary Outcome Measures

Name	Time	Method
SpO2 Accuracy	60 minutes	Collect and analyze data to determine SpO2 accuracy of oximeters under test.

Trial Locations

Locations (1)

UCSF Hypoxia Lab; 🇺🇸 San Francisco, California, United States