CLINICAL TRIALS

THE “SOMBRERO” STUDY

Published on ClinicalTrials.gov ID: NCT04810221

AIM OF THE STUDY

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% SpO2.

The study will be performed on a group of healthy volunteers in a controlled clinical setting.

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.

THE OBSERVER CLINICAL TRIAL

OBSERVER: cOntinuous , reliaBle , noninvaSive rEcoRd of Vital paramEters in Real life

AIM OF THE STUDY

To obtain continuous recording of Oxygen saturation and pulse frequency in stable patients suffering from chronic RF, treated with LTOT.
The primary outcome is to evaluate the reproducibility and consistency of the measurements.
The secondary outcome is to verify the appropriateness of the LTOT prescription

EXPECTED RESULTS

A difference within 3% between the SpO2 measured by BrOxy vs. the blood gas analysis and HR measured by BrOxy vs. EKG.

SpO2 variability within 2% during the three day period, after adjustment for physical activity.