An interventional study of Controlled desaturation study in Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M, sponsored by Life Meter srl. Completed at 1 site in Italy. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-20.
Sponsored by Life Meter srl · Not applicable, Interventional, and Diagnostic
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.
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.
This is the only study on the registry with Life Meter srl as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Presence of at least one of the following altered hemoglobin parameters at screening:
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.
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.
Time frame: 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.
Time frame: The test started around 2 minutes after beginning of the test session and ended after around 33 minutes.
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.
Time frame: 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
Time frame: After around 10 min after beginning of the test session
| Milestone | Experimental |
|---|---|
| Started | 16 |
| Completed | 13 |
| Not completed | 3 |
| Withdrew: Physician decision | 3 |
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.
| A(RMS) - % | Experimental |
|---|---|
| Accuracy of SpO2 Measurement at 80-100% SpO2 | 2.7 (-5.1 to 5.5) |
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.
| bpm | Experimental |
|---|---|
| Accuracy of Heart Rate Measurement at 80-100% SpO2 | 3.7 (-7.1 to 7.7) |
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.
| Cohen's kappa coefficient | Experimental |
|---|---|
| Agreement Between Broxy M and Reference Device SpO2 Measurements - Cut Off at 94% SpO2 | 0.79 |
Cohen's kappa coefficient to evaluate the agreement between Broxy M and the reference device for 90% SpO2 cut off
| Cohen's kappa coefficient | Experimental |
|---|---|
| Agreement Between Broxy M and the Reference Device SpO2 Measurements - Cut Off at 90% SpO2 | 0.80 |
Collected over The reporting period for adverse events was from the day the subject performed screening examinations until study exit (ie around 1-2 days).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
SpO2and HR paired measurements were obtained in parallel from the reference device and BrOxy M. The final number of data pairs included in the statistical analyses was 219.
| Age, Continuous(years) | Experimental |
|---|---|
| Mean | 37 ± 9 |
| Sex: Female, Male(Participants) | Experimental |
|---|---|
| Female | 2 |
| Male | 10 |
| Race and Ethnicity Not Collected(Participants) | Experimental |
|---|
| Skin pigmentation(Participants) | Experimental |
|---|---|
| Skin black | 4 |
| skin white | 8 |
| Body/Mass Index (BMI)(kg/m^2) | Experimental |
|---|---|
| Mean | 26.2 ± 3.3 |
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