Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy MSOMBRERONCT04810221
Postmarket Clinical Follow-up Study to Confirm the Performance of the Wearable Pulse-Oximeter BrOxy M (SOMBRERO)
A study of Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M, run by Life Meter srl at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteItaly
- Study dates
- 24 Mar 2021to 12 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects of both sexes with an age ≥ 18 and ≤ 50.
- American Society of Anesthesiology (ASA) classification 1
- Positive Allen's test
- Intact and healthy skin on the selected wrist
- Wrist circumference diameter between 150 mm e 200 mm.
- Normal electrocardiogram (ECG) obtained at screening or within 2 months prior to screening
- Ability to understand and execute the required study procedures and provide an informed consent to the study
Who cannot join
- Presence of at least one of the following altered hemoglobin parameters at screening:
- Alpha-hemoglobin (αHb) ≤ 10 gr/dl
- Carboxy-hemoglobin (COHb) ≥ 3%
- Methaemoglobin (MetHb) ≥ 2%
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postmarket Clinical Follow-up Study (PMCF) to Confirm the Performance of the Wearable Pulse-Oximeter BrOxy M
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.
Read the 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.
- Conditions
- Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M
- Being tested
- Controlled desaturation study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled desaturation studyOther
Measure of SpO2 and Heart Rate by BrOxy M device and reference device in a controlled desaturation study.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Measure of SpO2 and HR obtained in enrolled subjects using BrOxy M and a reference pulse oximeter in paired observations Receives: Other: Controlled desaturation study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The test started around 2 minutes after beginning of the test session and ended after around 33 minutes.
Secondary outcomes (2)
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.
Measured: 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
Measured: After around 10 min after beginning of the test session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start24 Mar 2021
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy MStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life Meter srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefano Marinari, Medicine, Principal investigator, Ospedale "SS. Annunziata", Via dei Vestini, 66100 Chieti, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810221
- Sponsor's protocol ID
- 01M2020-CH.LMD
- Acronym
- SOMBRERO
- Status last verified
- Feb 2022
- First submitted
- 18 Mar 2021
- Last updated
- 20 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarket Clinical Follow-up Study (PMCF) to Confirm the Performance of the Wearable Pulse-Oximeter BrOxy M
- ClinicalTrials.gov ID
- NCT04810221
- Acronym / sponsor ID
- SOMBRERO / 01M2020-CH.LMD
- Conditions
- Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Life Meter srlIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Posted 20 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Controlled desaturation studyMeasure of SpO2 and HR obtained in enrolled subjects using BrOxy M and a reference pulse oximeter in paired observations |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy subjects of both sexes with an age ≥ 18 and ≤ 50.
- American Society of Anesthesiology (ASA) classification 1
- Positive Allen's test
- Intact and healthy skin on the selected wrist
- Wrist circumference diameter between 150 mm e 200 mm.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled desaturation studyMeasure of SpO2 and Heart Rate by BrOxy M device and reference device in a controlled desaturation study. | Other | Experimental |
Primary outcome
Accuracy of SpO2 Measurement at 80-100% SpO2
Time frame: 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
Time frame: 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.
2 secondary outcomes
Agreement Between Broxy M and Reference Device SpO2 Measurements - Cut Off at 94% SpO2
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
Time frame: After around 10 min after beginning of the test session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Marinari, Medicine principal investigator
Ospedale "SS. Annunziata", Via dei Vestini, 66100 Chieti, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M, run by Life Meter srl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of SpO2 Measurement at 80-100% SpO2 (time frame: The measures started around 2 minutes after beginning of the test session and ended around 33 minutes later.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.