N/A
Completed N=16
Postmarket Clinical Follow-up Study to Confirm the Performance of the Wearable Pulse-Oximeter BrOxy M (SOMBRERO)
Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M
Source: ClinicalTrials.gov NCT04810221 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcomePrimary: Accuracy of SpO2 Measurement at 80-100% SpO2 — 2.7 A(RMS) - % — p=0.31
Summary
This study is a post market clinical follow up study performed to confirm the performance of BrOxy M pulse oximeter in comparison with a reference, CE marked, pulse oximeter equipment in a controlled desaturation study over a range between 80% and 100% peripheral oxygen saturation (SpO2).
The study will be performed on a group of healthy volunteers in a controlled clinical setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of SpO2 Measurement at 80-100% SpO2 |
2.7 | 0.31 |
| PRIMARY Accuracy of Heart Rate Measurement at 80-100% SpO2 |
3.7 | 0.32 |
| SECONDARY Agreement Between Broxy M and Reference Device SpO2 Measurements - Cut Off at 94% SpO2 |
0.79 | — |
| SECONDARY Agreement Between Broxy M and the Reference Device SpO2 Measurements - Cut Off at 90% SpO2 |
0.80 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy subjects of both sexes with an age ≥ 18 and ≤ 50.
- American Society of Anesthesiology (ASA) classification 1
- Positive Allen's test
- Intact and healthy skin on the selected wrist
- Wrist circumference diameter between 150 mm e 200 mm.
- Normal electrocardiogram (ECG) obtained at screening or within 2 months prior to screening
- Ability to understand and execute the required study procedures and provide an informed consent to the study
Exclusion Criteria
- Presence of at least one of the following altered hemoglobin parameters at screening:
- Alpha-hemoglobin (αHb) ≤ 10 gr/dl
- Carboxy-hemoglobin (COHb) ≥ 3%
- Methaemoglobin (MetHb) ≥ 2%
- For pre-menopausal female subjects only: positive pregnancy test performed at screening on urines or capillary blood
- Presence of any cardiovascular pathology in medical history.
- Any episodes of respiratory infection during the 30 days prior to screening
- Any prior experience of Dyspnea
- Hospitalization during the 2 months prior to screening, for any reason.
- Chronic drug intake known to interfere with gaseous exchanges or induce changes in cardiac frequency
- Presence of any medical condition not allowing the subject to perform the required test
- Known allergy to adhesive tapes
- Participation in an interventional study with a medicinal product or a medical device in the 30 days prior to screening.
Data sourced from ClinicalTrials.gov (NCT04810221). 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. Informational only — not medical advice.