Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M
Conditions
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.
Interventions
OTHERControlled desaturation study
Measure of SpO2 and Heart Rate by BrOxy M device and reference device in a controlled desaturation study.
Sponsors
Life Meter srl
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of SpO2 Measurement at 80-100% SpO2 | The measures started around 2 minutes after beginning of the test session and ended around 33 minutes later. | 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. |
| Accuracy of Heart Rate Measurement at 80-100% SpO2 | The test started around 2 minutes after beginning of the test session and ended after around 33 minutes. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between Broxy M and Reference Device SpO2 Measurements - Cut Off at 94% SpO2 | Around 5 min after beginning of the test session | 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. |
| Agreement Between Broxy M and the Reference Device SpO2 Measurements - Cut Off at 90% SpO2 | After around 10 min after beginning of the test session | Cohen's kappa coefficient to evaluate the agreement between Broxy M and the reference device for 90% SpO2 cut off |
Countries
Italy
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Measure of SpO2 and heart rate (HR) obtained in enrolled subjects using BrOxy M and a reference pulse oximeter in paired observations | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
Baseline characteristics
| Characteristic | Experimental | — |
|---|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 9 | — |
| Body/Mass Index (BMI) | 26.2 kg/m^2 STANDARD_DEVIATION 3.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
| Skin pigmentation Skin black | 4 Participants | — |
| Skin pigmentation skin white | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: The test started around 2 minutes after beginning of the test session and ended after around 33 minutes.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental | Accuracy of Heart Rate Measurement at 80-100% SpO2 | 3.7 bpm |
p-value: 0.3295% CI: [-0.24, 0.75]Paired T test 0
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.
Time frame: The measures started around 2 minutes after beginning of the test session and ended around 33 minutes later.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental | Accuracy of SpO2 Measurement at 80-100% SpO2 | 2.7 A(RMS) - % |
p-value: 0.3195% CI: [-0.17, 0.54]Paired T-test 0
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.
Time frame: Around 5 min after beginning of the test session
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental | Agreement Between Broxy M and Reference Device SpO2 Measurements - Cut Off at 94% SpO2 | 0.79 Cohen's kappa coefficient |
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
Time frame: After around 10 min after beginning of the test session
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental | Agreement Between Broxy M and the Reference Device SpO2 Measurements - Cut Off at 90% SpO2 | 0.80 Cohen's kappa coefficient |