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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.
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 (Nellcorâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Measure of SpO2 and HR obtained in enrolled subjects using BrOxy M and a reference pulse oximeter in paired observations |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Controlled desaturation study | Other | Measure of SpO2 and Heart Rate by BrOxy M device and reference device in a controlled desaturation study. |
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| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Presence of at least one of the following altered hemoglobin parameters at screening:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Marinari, Medicine | Ospedale "SS. Annunziata", Via dei Vestini, 66100 Chieti, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale "SS. Annunziata" | Chieti | 66100 | Italy |
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A total of 19 subjects signed the informed consent and were screened for participating in the study. Of these, 3 subjects were smokers with carboxyhemoglobin (COHb) ≥ 3% and were considered screen failures. The remaining 16 were eligible and were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Measure of peripheral oxygen saturation (SpO2) and heart rate (HR) obtained in enrolled subjects using BrOxy M and a reference pulse oximeter in paired observations |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2020 |
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| 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 |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Measure of SpO2 and heart rate (HR) obtained in enrolled subjects using BrOxy M and a reference pulse oximeter in paired observations |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Skin pigmentation | Black or white skin | Count of Participants | Participants |
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| Body/Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | A(RMS) - % | The measures started around 2 minutes after beginning of the test session and ended around 33 minutes later. |
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | bpm | The test started around 2 minutes after beginning of the test session and ended after around 33 minutes. |
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| Secondary | 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. | Posted | Number | Cohen's kappa coefficient | Around 5 min after beginning of the test session |
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| Secondary | 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 | Posted | Number | Cohen's kappa coefficient | After around 10 min after beginning of the test session | data pairs | data pairs |
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The reporting period for adverse events was from the day the subject performed screening examinations until study exit (ie around 1-2 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Measure of SpO2 and heart rate (HR) obtained in enrolled subjects using BrOxy M and a reference pulse oximeter in paired observations | 0 | 12 | 0 | 12 | 0 | 12 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fernando De Benedetto/President | Life Meter Srl | +39 391 4334 090 | fernando.debenedetto@lifemetersrl.com |
| Dec 3, 2021 |
| Prot_SAP_000.pdf |
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| data pairs |
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