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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Other: Controlled desaturation study


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Measure of SpO2 and HR obtained in enrolled subjects using BrOxy M and a reference pulse oximeter in paired observations | Other: Controlled desaturation study<br>* Measure of SpO2 and Heart Rate by BrOxy M device and reference device in a controlled desaturation study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of SpO2 Measurement at 80-100% SpO2 | Accuracy of SpO2 measurements obtained with BrOxy M in comparison with the reference pulse oximeter in paired observations over a range between 80% and 100% SpO2. Based on the standard ISO 80601-2-61:2017, the accuracy is stated in terms of the root-mean-square difference between the readings of the BrOxy M and the standard readings of the reference pulse oximeter. | The measures started around 2 minutes after beginning of the test session and ended around 33 minutes later. | 
| Accuracy of Heart Rate Measurement at 80-100% SpO2 | Accuracy of measurements obtained with BrOxy M with that obtained with the reference pulse oximeter in paired observations. Based on the standard ISO 80601-2-61:2017, the accuracy is stated in terms of the root-mean-square difference between the readings of the BrOxy M and the standard readings of the reference pulse oximeter. | The test started around 2 minutes after beginning of the test session and ended after around 33 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement Between Broxy M and Reference Device SpO2 Measurements - Cut Off at 94% SpO2 | Cohen's kappa coefficient to evaluate the agreement between Broxy M and the reference device for 94% SpO2 cut off. Cohen's kappa coefficient takes into account the possibility of agreement occurring by chance. | Around 5 min after beginning of the test session | 
| Agreement Between Broxy M and the Reference Device SpO2 Measurements - Cut Off at 90% SpO2 | Cohen's kappa coefficient to evaluate the agreement between Broxy M and the reference device for 90% SpO2 cut off | After around 10 min after beginning of the test session |