Status:
COMPLETED
Postmarket Clinical Follow-up Study to Confirm the Performance of the Wearable Pulse-Oximeter BrOxy M (SOMBRERO)
Lead Sponsor:
Life Meter srl
Conditions:
Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 ...
Detailed Description
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 (Nellcor™ Bedsid...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04810221
Start Date
March 24 2021
End Date
April 12 2021
Last Update
April 20 2022
Active Locations (1)
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1
Ospedale "SS. Annunziata"
Chieti, Italy, 66100