AnoxiaNCT02842476
Accuracy Validation of the Cadwell Pulse Oximetry System
An observational study of Anoxia, run by Cadwell Industries, Inc..
Trial summary
The purpose of this study is to evaluate the SpO2 accuracy and performance of the Cadwell Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anoxia
- What is being tested?
- Disposable Sensor and Reusable Sensor
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2016
- Phase
- Observational
- 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
Study population: Following Salus Independent Review Board (IRB) approval for the Study Procedure Title: "Accuracy Validation of the Cadwell Pulse Oximetry System", Clinimark Study ID# PR 2016-177, eleven healthy adult volunteer subjects were enrolled into the study. The demographics for the study included five males and six females (age: 21-46yrs, weight: 118-220lbs, height: 60-74", BMI: 20.9-30.7). For the demographics based on race, the subject pool included one Black / African-American, three Asians (one of Indian descent), and seven White. The ethnicity for the group is four Hispanic, and seven Non-Hispanic / Non-Latino. The skin pigmentation / tones ranged from light to dark meeting the requirement of at least 2 darkly pigmented or 15 % of the subject pool whichever is larger.
Who may be able to join
- Ability to understand and provide written informed consent
- 18 to 50 years of age
- Non-smoker or who has not smoked within 2 days prior to the study.
- Male or female
- Any race
Who cannot join
- Morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull
- Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
- COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow)
- Respiratory conditions
- Heart or cardiovascular conditions
Show all 11Show fewer
- Self reported health conditions
- Blood clotting disorders
- Severe contact allergies to standard adhesives, latex or other materials
- Unwillingness or inability to remove colored nail polish from test digits
- Other known health condition, should be considered upon disclosure in health
About this study
The purpose of this study is to evaluate the SpO2 accuracy and performance of the Cadwell Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the Cadwell Pulse Oximetry System. It is expected that the Accuracy Root Mean Square (Arms) performance of the Cadwell Pulse Oximetry System will meet a specification of 3 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.
Read the detailed description
The SpO2 accuracy performance of the Cadwell Pulse Oximetry systems will be evaluated during non-motion conditions over the range of 70-100% SaO2 and compared to arterial blood samples assessed by COOximetry. A minimum of 10 healthy adult subjects, ranging in pigmentation from light to dark, will be enrolled in the study to meet the study design requirements defined by ISO 80601-2-61 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). The subjects will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels. The investigational devices will be placed on fingers for the test sites. Simultaneous data collection will be set up for each of the systems under test.
For the data analysis, the control oximeter will be used to assess the stability of each data point. Data that is found to be unstable will be removed prior to the comparative analysis. Next the CO-Oximeter data will be reviewed to make sure it does not contain any anomalous values such as elevated COHb, MetHb or inconsistent data. Anomalous values will be removed from the analysis prior to pairing of the SpO2 and SaO2 data. The statistical analysis is performed on a minimum of 200 data points collected on at least 10 subjects for the range of 67% to 100% SaO2. Functional SaO2 as measured by Reference CO-Oximetry will be used as the basis for comparison. The Accuracy Root Mean Square (ARMS) calculation is used to determine the SpO2 accuracy performance. Success will be achieved with an ARMS of 3 or better showing equivalence to the Gold Standard Reference CO-Oximetry providing documentation to support SpO2 accuracy claims for the investigational device.
- Conditions
- Anoxia
- Being tested
- Disposable Sensor, Reusable Sensor, Control Pulse Oximetry
- Keywords
- pulse oximetry
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disposable SensorDevice
Also called Model S0136J-L
Two adhesive based Pulse Oximeter Probes, S0136J-L were connected to the Cadwell Pulse Oximetry and then placed on each subject to evaluate the SpO2 accuracy performance during steady state non-motion conditions.
Reusable SensorDevice
Also called Model S0080D-S
Two soft reusable Pulse Oximeter Probes, Model S0080D-S were connected to the Cadwell Pulse Oximetry and then placed on each subject to evaluate the SpO2 accuracy performance during steady state non-motion conditions.
Control Pulse OximetryDevice
Also called Reference Co-Oximeters, ABL80 Flex OSM (Radiometer): # 302125, 307205 IL682 (Instrumentation Laboratories): # 012511B (ILH), #012511A (ILG)
A Clinimark Control Pulse Oximetry system was also placed on the subject to evaluate the stability of the draws.
| Study group | Role | What they receive |
|---|---|---|
| Disposable Sensor | Adhesive based Pulse Oximeter Probes, Model S0136J Receives: Device: Disposable Sensor | |
| Reusable Sensor | Reusable Pulse Oximeter Probes, Model S0080D Receives: Device: Reusable Sensor | |
| Control Pulse Oximetry | Reference CO-Oximeters ABL80 Flex OSM (Radiometer), # 302125, 307205 IL682 (Instrumentation Laboratories), # 012511B (ILH), #012511A (ILG) Receives: Device: Control Pulse Oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 Sensor Values
SpO2 values (%) from the Cadwell pulse oximetry device using disposable and reusable sensors were collected electronically at one second intervals.
Measured: Through study completion, an average of 1 day
Secondary outcomes (1)
Arterial Oxygen Saturation
Each subject was presented with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% and 67% SaO2. Arterial blood draws were collected under non-motion conditions. The blood was immediately analyzed to measure the arterial oxygen saturation.
Measured: Through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnoxiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cadwell Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842476
- Sponsor's protocol ID
- PR 2016-177
- Status last verified
- Jul 2016
- First submitted
- 15 Jul 2016
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Validation of the Cadwell Pulse Oximetry System
- ClinicalTrials.gov ID
- NCT02842476
- Acronym / sponsor ID
- PR 2016-177
- Conditions
- Anoxia
- Keywords
- pulse oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cadwell Industries, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Study start
- Jun 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Jul 2016 (estimated)
- 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 and performance of the Cadwell Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the Cadwell Pulse Oximetry System. It is expected that the Accuracy Root Mean Square (Arms) performance of the Cadwell Pulse Oximetry System will meet a specification of 3 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.
Detailed description
The SpO2 accuracy performance of the Cadwell Pulse Oximetry systems will be evaluated during non-motion conditions over the range of 70-100% SaO2 and compared to arterial blood samples assessed by COOximetry. A minimum of 10 healthy adult subjects, ranging in pigmentation from light to dark, will be enrolled in the study to meet the study design requirements defined by ISO 80601-2-61 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). The subjects will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels. The investigational devices will be placed on fingers for the test sites. Simultaneous data collection will be set up for each of the systems under test.
For the data analysis, the control oximeter will be used to assess the stability of each data point. Data that is found to be unstable will be removed prior to the comparative analysis. Next the CO-Oximeter data will be reviewed to make sure it does not contain any anomalous values such as elevated COHb, MetHb or inconsistent data. Anomalous values will be removed from the analysis prior to pairing of the SpO2 and SaO2 data. The statistical analysis is performed on a minimum of 200 data points collected on at least 10 subjects for the range of 67% to 100% SaO2. Functional SaO2 as measured by Reference CO-Oximetry will be used as the basis for comparison. The Accuracy Root Mean Square (ARMS) calculation is used to determine the SpO2 accuracy performance. Success will be achieved with an ARMS of 3 or better showing equivalence to the Gold Standard Reference CO-Oximetry providing documentation to support SpO2 accuracy claims for the investigational device.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Disposable Sensor | – | Device: Disposable SensorAdhesive based Pulse Oximeter Probes, Model S0136J |
| Reusable Sensor | – | Device: Reusable SensorReusable Pulse Oximeter Probes, Model S0080D |
| Control Pulse Oximetry | – | Device: Control Pulse OximetryReference CO-Oximeters ABL80 Flex OSM (Radiometer), # 302125, 307205 IL682 (Instrumentation Laboratories), # 012511B (ILH), #012511A (ILG) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Following Salus Independent Review Board (IRB) approval for the Study Procedure Title: "Accuracy Validation of the Cadwell Pulse Oximetry System", Clinimark Study ID# PR 2016-177, eleven healthy adult volunteer subjects were enrolled into the study. The demographics for the study included five males and six females (age: 21-46yrs, weight: 118-220lbs, height: 60-74", BMI: 20.9-30.7). For the demographics based on race, the subject pool included one Black / African-American, three Asians (one of Indian descent), and seven White. The ethnicity for the group is four Hispanic, and seven Non-Hispanic / Non-Latino. The skin pigmentation / tones ranged from light to dark meeting the requirement of at least 2 darkly pigmented or 15 % of the subject pool whichever is larger.
Key inclusion criteria (5 listed)
- Ability to understand and provide written informed consent
- 18 to 50 years of age
- Non-smoker or who has not smoked within 2 days prior to the study.
- Male or female
- Any race
Key exclusion criteria (11 listed)
- Morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull
- Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
- COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow)
- Respiratory conditions
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 |
|---|---|---|
| Disposable SensorAlso: Model S0136J-LTwo adhesive based Pulse Oximeter Probes, S0136J-L were connected to the Cadwell Pulse Oximetry and then placed on each subject to evaluate the SpO2 accuracy performance during steady state non-motion conditions. | Device | Disposable Sensor |
| Reusable SensorAlso: Model S0080D-STwo soft reusable Pulse Oximeter Probes, Model S0080D-S were connected to the Cadwell Pulse Oximetry and then placed on each subject to evaluate the SpO2 accuracy performance during steady state non-motion conditions. | Device | Reusable Sensor |
| Control Pulse OximetryAlso: Reference Co-Oximeters, ABL80 Flex OSM (Radiometer): # 302125, 307205 IL682 (Instrumentation Laboratories): # 012511B (ILH), #012511A (ILG)A Clinimark Control Pulse Oximetry system was also placed on the subject to evaluate the stability of the draws. | Device | Control Pulse Oximetry |
Primary outcome
SpO2 Sensor Values
Time frame: Through study completion, an average of 1 day
SpO2 values (%) from the Cadwell pulse oximetry device using disposable and reusable sensors were collected electronically at one second intervals.
1 secondary outcome
Arterial Oxygen Saturation
Time frame: Through study completion, an average of 1 day
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 25 Jul 2016.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Anoxia, run by Cadwell Industries, Inc..
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 5 inclusion and 11 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 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Sensor Values (time frame: Through study completion, an average of 1 day). 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 25 Jul 2016.