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

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

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.

Study Overview

• Status: Completed
• Conditions: Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M
• Intervention / Treatment: Other: Controlled desaturation study

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™ 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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Chieti, Italy, 66100
    • Ospedale "SS. Annunziata"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Life Meter srl
• Investigators: Principal Investigator: Stefano Marinari, Medicine, Ospedale "SS. Annunziata", Via dei Vestini, 66100 Chieti, Italy

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Actual): April 12, 2021
• Study Completion (Actual): April 12, 2021

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 01M2020-CH.LMD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No