Validation StudyS2-SOPRAVNCT05386836
The Sunrise SpO2 and Pulse Rate Accuracy Validation Study
A study testing Pulse oximeter validation population in people with Validation Study, run by Sunrise at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Validation Study
- What is being tested?
- Pulse oximeter validation population
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 24 May 2022to 21 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subjects with positive Allen's test
- Subject must be willing and able to comply with study procedures and duration
- Subject is a non-smoker or who has not smoked within 2 days prior to the study
- 15% of the study population or 2 subjects (whichever is larger) with dark pigmented skin should be included in the study
Who cannot join
- Subject is considered as being morbidly obese (defined as BMI >39.5)
- Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
- Subjects with known heart or cardiovascular conditions
- Subjects with other known health condition (diabetes, thyroid disease, kidney disease/chronic renal impairment, history of seizures (except childhood febrile seizures) or epilepsy, or unexplained syncope, recent history of frequent migraine headaches, recent head injury, cancer/chemotherapy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center Study Assessing the SpO2 and Pulse Rate Accuracy of the Sunrise Sensor 2 Compared to Arterial Blood Samples Oxygen Saturation Assessed by CO-oximetry and ECG Respectively, Under Non-motion Conditions in Healthy Adults
The purpose of this study is to evaluate the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter. Testing is conducted under normal office environment conditions. It is expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system will meet the required specification of ARMS of 3.5% or less allowed for reflectance technology in non-motion conditions for the range of 70-100% SaO2.
A secondary goal is to evaluate the pulse rate performance simultaneously collected over the SpO2 range covered.
Read the detailed description
Subjects will be given medical grade mixtures of oxygen and nitrogen to induce stable plateaus across the range of 100% to 70% SaO2. When the reference system's blood saturation stabilizes at an acceptable plateau level, blood sampling can start. Four to eight arterial blood samples will be collected for each plateau, while keeping at least 20 seconds in between each sample and at least 30 seconds once the plateau has been reached. The blood will be immediately analyzed by the reference CO-Oximeter to measure the arterial oxygen saturation (Functional SaO2). SpO2 values from the Sunrise sensor 2 will be collected electronically simultaneously to blood drawn from the indwelling catheter. Data will be collected under non-motion conditions. The pulse rate will be simultaneously collected over the SpO2 range covered. The reference method for the computation of pulse rate accuracy will be an ECG heart rate. The total duration of the test will be about 1 hour per subject. Data analysis results will provide documentation showing SpO2 and pulse rate accuracy performance of the Sunrise sensor 2 as compared to arterial blood samples measured by Reference CO-Oximetry and to ECG heart rate, respectively.
- Conditions
- Validation Study
- Being tested
- Pulse oximeter validation population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximeter validation populationDevice
Evaluation of the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adult volunteers | Experimental | All subjects within this single arm of the study will undergo the validation experiment as described in the description Receives: Device: Pulse oximeter validation population |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 ARMS determination
SpO2 accuracy root-mean-square (ARMS) determination for the range of 70- 100%., i.e., the RMS difference between measured values and reference values.
Measured: Within 1 month after subject recruitment
Secondary outcomes (1)
Pulse rate ARMS determination
Pulse rate accuracy root-mean-square (ARMS) determination
Measured: Within 1 month after subject recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start24 May 2022
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation StudyStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunrise
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386836
- Sponsor's protocol ID
- PRO-367
- Acronym
- S2-SOPRAV
- Status last verified
- Jun 2022
- First submitted
- 18 May 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- 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 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Study Assessing the SpO2 and Pulse Rate Accuracy of the Sunrise Sensor 2 Compared to Arterial Blood Samples Oxygen Saturation Assessed by CO-oximetry and ECG Respectively, Under Non-motion Conditions in Healthy Adults
- ClinicalTrials.gov ID
- NCT05386836
- Acronym / sponsor ID
- S2-SOPRAV / PRO-367
- Conditions
- Validation Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- SunriseIndustry (pharma, biotech, devices)
- Study start
- 24 May 2022 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter. Testing is conducted under normal office environment conditions. It is expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system will meet the required specification of ARMS of 3.5% or less allowed for reflectance technology in non-motion conditions for the range of 70-100% SaO2.
A secondary goal is to evaluate the pulse rate performance simultaneously collected over the SpO2 range covered.
Detailed description
Subjects will be given medical grade mixtures of oxygen and nitrogen to induce stable plateaus across the range of 100% to 70% SaO2. When the reference system's blood saturation stabilizes at an acceptable plateau level, blood sampling can start. Four to eight arterial blood samples will be collected for each plateau, while keeping at least 20 seconds in between each sample and at least 30 seconds once the plateau has been reached. The blood will be immediately analyzed by the reference CO-Oximeter to measure the arterial oxygen saturation (Functional SaO2). SpO2 values from the Sunrise sensor 2 will be collected electronically simultaneously to blood drawn from the indwelling catheter. Data will be collected under non-motion conditions. The pulse rate will be simultaneously collected over the SpO2 range covered. The reference method for the computation of pulse rate accuracy will be an ECG heart rate. The total duration of the test will be about 1 hour per subject. Data analysis results will provide documentation showing SpO2 and pulse rate accuracy performance of the Sunrise sensor 2 as compared to arterial blood samples measured by Reference CO-Oximetry and to ECG heart rate, respectively.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adult volunteers | Experimental | Device: Pulse oximeter validation populationAll subjects within this single arm of the study will undergo the validation experiment as described in the description |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects with positive Allen's test
- Subject must be willing and able to comply with study procedures and duration
- Subject is a non-smoker or who has not smoked within 2 days prior to the study
- 15% of the study population or 2 subjects (whichever is larger) with dark pigmented skin should be included in the study
Key exclusion criteria (4 listed)
- Subject is considered as being morbidly obese (defined as BMI >39.5)
- Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
- Subjects with known heart or cardiovascular conditions
- Subjects with other known health condition (diabetes, thyroid disease, kidney disease/chronic renal impairment, history of seizures (except childhood febrile seizures) or epilepsy, or unexplained syncope, recent history of frequent migraine headaches, recent head injury, cancer/chemotherapy)
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 |
|---|---|---|
| Pulse oximeter validation populationEvaluation of the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter. | Device | Healthy adult volunteers |
Primary outcome
SpO2 ARMS determination
Time frame: Within 1 month after subject recruitment
SpO2 accuracy root-mean-square (ARMS) determination for the range of 70- 100%., i.e., the RMS difference between measured values and reference values.
1 secondary outcome
Pulse rate ARMS determination
Time frame: Within 1 month after subject recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse oximeter validation population in people with Validation Study, run by Sunrise at 1 site in Belgium.
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 4 inclusion and 4 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 28 Jun 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SpO2 ARMS determination (time frame: Within 1 month after subject recruitment). 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 28 Jun 2022.