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

Life Meter srl

Status: Completed

Conditions: Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M

Treatments: Other: Controlled desaturation study

Study type: Interventional

Funder types: Industry

Identifiers

NCT04810221

01M2020-CH.LMD

Details and patient eligibility

About

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.

Full 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™ 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy subjects of both sexes with an age ≥ 18 and ≤ 50.
2. American Society of Anesthesiology (ASA) classification 1
3. Positive Allen's test
4. Intact and healthy skin on the selected wrist
5. Wrist circumference diameter between 150 mm e 200 mm.
6. Normal electrocardiogram (ECG) obtained at screening or within 2 months prior to screening
7. Ability to understand and execute the required study procedures and provide an informed consent to the study

Exclusion criteria

1. Presence of at least one of the following altered hemoglobin parameters at screening:

   1. Alpha-hemoglobin (αHb) ≤ 10 gr/dl
   2. Carboxy-hemoglobin (COHb) ≥ 3%
   3. Methaemoglobin (MetHb) ≥ 2%

2. For pre-menopausal female subjects only: positive pregnancy test performed at screening on urines or capillary blood

3. Presence of any cardiovascular pathology in medical history.

4. Any episodes of respiratory infection during the 30 days prior to screening

5. Any prior experience of Dyspnea

6. Hospitalization during the 2 months prior to screening, for any reason.

7. Chronic drug intake known to interfere with gaseous exchanges or induce changes in cardiac frequency

8. Presence of any medical condition not allowing the subject to perform the required test

9. Known allergy to adhesive tapes

10. Participation in an interventional study with a medicinal product or a medical device in the 30 days prior to screening.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Experimental

Experimental group

Description:

Measure of SpO2 and HR obtained in enrolled subjects using BrOxy M and a reference pulse oximeter in paired observations

Treatment:

Other: Controlled desaturation study