N/A
N=14
Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia
Oximetry
Bottom Line
View on ClinicalTrials.gov: NCT04380389 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: RMSE Compared to CO-oximetry — 2.97; 3.00 RMSE (%)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- hypoxia (Diagnostic_test)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Withings
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY RMSE Compared to CO-oximetry |
2.97; 3.00 | — |
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.
- The subject has piercings that may cause air leaks during the test
- The subject has 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 a resting heartrate over 120, Systolic BP is over 150, diastolic BP is over 90 or room air SpO2 is less than 94%.
- The subject has carboxyhemoglobin over 3% as measured by Lab blood gas analysis.
- The subject has any other condition, which in the opinion of the investigators' would make them unsuitable to participate.
Data sourced from ClinicalTrials.gov (NCT04380389). 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.