Clinical trial NCT04810221: Postmarket Clinical Follow-up Study to Confirm the Performance of the Wearable Pulse-Oximeter BrOxy M (SOMBRERO)
Official title: Postmarket Clinical Follow-up Study (PMCF) to Confirm the Performance of the Wearable Pulse-Oximeter BrOxy M
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M
Lead sponsor: Life Meter srl
Sponsor class: INDUSTRY
First posted: 2021-03-22
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of SpO2 Measurement at 80-100% SpO2
timeFrame: The measures started around 2 minutes after beginning of the test session and ended around 33 minutes later.
measure: Accuracy of Heart Rate Measurement at 80-100% SpO2
timeFrame: The test started around 2 minutes after beginning of the test session and ended after around 33 minutes.
Secondary outcomes:
measure: Agreement Between Broxy M and Reference Device SpO2 Measurements - Cut Off at 94% SpO2
timeFrame: Around 5 min after beginning of the test session
measure: Agreement Between Broxy M and the Reference Device SpO2 Measurements - Cut Off at 90% SpO2
timeFrame: After around 10 min after beginning of the test session
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Ospedale "SS. Annunziata"
Study officials:
affiliation: Ospedale "SS. Annunziata", Via dei Vestini, 66100 Chieti, Italy
name: Stefano Marinari, Medicine
role: PRINCIPAL_INVESTIGATOR
References: