Postmarket Clinical Follow-up Study to Confirm the Performance of the Wearable Pulse-Oximeter BrOxy M (SOMBRERO)

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™ Bedside Respiratory Patient Monitoring System model PM1000N, Covidien LLC, USA) in a controlled desaturation study over a range between 80% and 100% SpO2.

The study will be performed on a group of healthy volunteers in a controlled clinical setting. Due to the use of a controlled desaturation protocol foreseen by the standard ISO 80601-2-61:2017, this study is classified as an interventional post-market clinical study in accordance with Annex I of EN ISO 14155:2020.

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.