HealthyNCT05141500
SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor
A study testing STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS in people with Healthy and Hypoxia, run by Stryker Sustainability Solutions at 1 site in United States.
Trial summary
The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2021to 3 Nov 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health with no evidence of pre-existing medical problems
- Fluent in both written and spoken English
- Must be able to review informed consent and is willing to comply with study procedures
Who cannot join
- Obesity (BMI >30)
- Known history of heart disease, lung disease, kidney or liver disease
- Prior diagnosis of asthma, sleep apnea, or use of CPAP
- Diabetes
- Clotting disorder
- Hemoglobinopathy or history of anemia that in the opinion of the investigators would make them unsuitable for study participation
Show all 16Show fewer
- Any serious systemic illness
- Current smoker
- Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigator would interfere with the sensors working correctly
- History of fainting or vasovagal response
- History of sensitivity to local anesthesia
- Prior diagnosis of Raynaud's disease
- Unacceptable collateral circulation based on exam by investigators (Allen's test)
- Pregnant, lactating, or trying to get pregnant
- Unable or unwilling to provide informed consent, or unable or unwilling to comply with study procedures
- Any other condition which in the opinion of the investigators would make them unsuitable for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Hypoxia Research Laboratory
San Francisco, California, 94133
About this study
The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors.
Read the detailed description
In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the participant breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.
It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse oximetry sensors will meet a specification of +/-3% or better in non-motion conditions for the range of 70 - 100% SaO2 (typically, saturation is determined once with air breathing and then at one of 6 levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% saturation for about 30-60 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification.
- Being tested
- STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERSDevice
Reprocessed noninvasive pulse oximeters
- 1859 \& 2329
- MAX-A \& MAX-N
| Study group | Role | What they receive |
|---|---|---|
| Healthy adult participants | Experimental | All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors Receives: Device: STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Sensor by Arms Calculation
Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 (arterial oxygen saturation) must meet the 3% specification for each reprocessed pulse oximetry sensor style. Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. Standard deviation of the differences is computed as the precision. Square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start2 Nov 2021
- Primary completion3 Nov 2021
- Study completion3 Nov 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 HealthyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be in a reclined position for the study. Reference sensors will be placed on each participant to evaluate the SpO2 accuracy and performance. Sensors may be placed on non-adjacent fingers to prevent optical crosstalk. Simultaneous data collection will be set up for devices under test. The data from the test devices will be collected by the sponsor or trained UCSF staff. Data will be collected for 1-2 second intervals data analysis. The SpO2 accuracy of the test devices will be evaluated over the oxygen saturation range between 70-100%.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Sustainability Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Philip E Bickler, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141500
- Sponsor's protocol ID
- CRD10302
- Status last verified
- Nov 2022
- First submitted
- 23 Nov 2021
- Last updated
- 21 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data to be used by Sponsor only
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor
- ClinicalTrials.gov ID
- NCT05141500
- Acronym / sponsor ID
- CRD10302
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stryker Sustainability SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Posted 21 Dec 2022
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 clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors.
Detailed description
In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the participant breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.
It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse oximetry sensors will meet a specification of +/-3% or better in non-motion conditions for the range of 70 - 100% SaO2 (typically, saturation is determined once with air breathing and then at one of 6 levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% saturation for about 30-60 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be in a reclined position for the study. Reference sensors will be placed on each participant to evaluate the SpO2 accuracy and performance. Sensors may be placed on non-adjacent fingers to prevent optical crosstalk. Simultaneous data collection will be set up for devices under test. The data from the test devices will be collected by the sponsor or trained UCSF staff. Data will be collected for 1-2 second intervals data analysis. The SpO2 accuracy of the test devices will be evaluated over the oxygen saturation range between 70-100%.
| Arm | Type | Receives |
|---|---|---|
| Healthy adult participants | Experimental | Device: STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERSAll participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Good general health with no evidence of pre-existing medical problems
- Fluent in both written and spoken English
- Must be able to review informed consent and is willing to comply with study procedures
Key exclusion criteria (16 listed)
- Obesity (BMI >30)
- Known history of heart disease, lung disease, kidney or liver disease
- Prior diagnosis of asthma, sleep apnea, or use of CPAP
- Diabetes
- Clotting disorder
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 |
|---|---|---|
| STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERSReprocessed noninvasive pulse oximeters * 1859 \& 2329 * MAX-A \& MAX-N | Device | Healthy adult participants |
Primary outcome
Accuracy of Sensor by Arms Calculation
Time frame: 1-2 hours
Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 (arterial oxygen saturation) must meet the 3% specification for each reprocessed pulse oximetry sensor style. Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. Standard deviation of the differences is computed as the precision. Square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data to be used by Sponsor only
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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.
Philip E Bickler, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS in people with Healthy and Hypoxia, run by Stryker Sustainability Solutions at 1 site in United States.
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 3 inclusion and 16 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 21 Dec 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 United States. 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 21 Dec 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 Sensor by Arms Calculation (time frame: 1-2 hours). 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 21 Dec 2022.