Oximetry
Conditions
Brief summary
This study to assess the oxygen saturation accuracy of the Beddr SleepTuner in profound hypoxia.
Interventions
DEVICEOximeter
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.
Sponsors
Hancock Medical, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 Accuracy | 60 minutes | Collect and analyze data to determine SpO2 accuracy of oximeters under test. |
Countries
United States
Outcome results
None listed