N/A
N=14
Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia
Hypoxia
Bottom Line
View on ClinicalTrials.gov: NCT04446247 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: SpO2 Accuracy (Arms) of ≤3 Between 70 and 100% — 2.10; 2.19 Percentage
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Owlet Smart Sock Sensor 3rd Generation (Diagnostic_test)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Owlet Baby Care, Inc.
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SpO2 Accuracy (Arms) of ≤3 Between 70 and 100% |
2.10; 2.19 | — |
Summary
Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.
Eligibility Criteria
Inclusion Criteria
- The subject is male or female, aged ≥18 and 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.
Data sourced from ClinicalTrials.gov (NCT04446247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.