HealthyNCT02506010
Accuracy Validation of a Pulse Oximetry Monitor
An observational study of Healthy, run by Medtronic - MITG at 1 site in United States.
Trial summary
The purpose of this study is to conduct an oxygen saturation (SpO2) accuracy validation comparing prototype pulse oximeter oxygen saturation measurements directly to arterial blood saturation during non-motion conditions over the range of 60-100% SaO2 as measured by Reference CO-Oximetry. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Jan 2017
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will be ten to fifteen male and female subjects of any race, ranging in pigmentation from light to dark to meet the study design requirements
Who may be able to join
- healthy
- non-smoking, or who have refrained from smoking for 2 days
- male or female of any race
- 18-45 years.
- Subjects must have the ability to understand and provide written informed consent as well as be willing to comply with study procedures.
- To be eligible to participate in the study, the subject must clear a recent physical (12-lead ECG, medical history and blood test for sickle cell disease.) prior to enrollment
Who cannot join
- - morbid obesity (defined as BMI > 39.5),
- injuries, deformities or abnormalities or piercings that may prevent proper application of the device under test, compromised circulation,
- subjects with known respiratory conditions (smokers with COHb levels >3%, flu, pneumonia, bronchitis, shortness of breath/ respiratory distress, severe asthma, emphysema, COPD),
- subjects with known heart or cardiovascular conditions (uncontrolled hypertension, heart arrhythmias other than sinus arrhythmia, previous heart attack, blocked artery, history of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy, history of stroke, transient ischemic attack or carotid artery disease),
- 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
- women actively trying to get pregnant or are pregnant,
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- clotting disorders (history of bleeding disorders or current use of blood thinners, Hemophilia, blood clots)
- Sickle cell disease
- Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors
- Unwillingness or inability to remove colored nail polish or artificial nails from test digit(s)
- Prior or known allergies to: lidocaine (or similar pharmacological agents, e.g., Novocain) or heparin
- Recent arterial cannulation (i.e., less than 30 days prior to study date), Six or more arterial cannulations of each (right \& left) radial artery, history of clinically significant complications from previous arterial cannulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SpO2 Accuracy Validation of a USB Pulse Oximetry Monitor Interface Cable Via Reference Co-Oximetry
The purpose of this study is to conduct an oxygen saturation (SpO2) accuracy validation comparing prototype pulse oximeter oxygen saturation measurements directly to arterial blood saturation during non-motion conditions over the range of 60-100% SaO2 as measured by Reference CO-Oximetry. Additionally, the prototype pulse oximeter pulse rate measurements will be compared to 3-lead ECG heart rate measurements made via a multi-parameter monitor.
Read the detailed description
The description of this study is to conduct an oxygen saturation (SpO2) accuracy validation comparing prototype pulse oximeter oxygen saturation measurements directly to arterial blood saturation during non-motion conditions over the range of 60-100% SaO2 as measured by Reference CO-Oximetry. Additionally, the prototype pulse oximeter pulse rate measurements will be compared to 3-lead ECG heart rate measurements made via a multi-parameter monitor.
- Conditions
- Healthy
- Keywords
- Hypoxia
- Medical subject headings
- Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
The OxiCable pulse rate measurement performance is an ARMS of 3 or better over the full range 60-100% SaO2.
Measured: 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startNov 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Why it stopped: Sponsor decided not to run this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Responsible party
- Sponsor
- Investigators
- David Ransom, MD, Principal investigator, Clinimark, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506010
- Sponsor's protocol ID
- COVMOPR0499
- Status last verified
- Oct 2016
- First submitted
- 14 Jul 2015
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: This study was cancelled.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpO2 Accuracy Validation of a USB Pulse Oximetry Monitor Interface Cable Via Reference Co-Oximetry
- ClinicalTrials.gov ID
- NCT02506010
- Acronym / sponsor ID
- COVMOPR0499
- Conditions
- Healthy
- Keywords
- Hypoxia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decided not to run this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Study start
- Nov 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 22 Jul 2015 (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 conduct an oxygen saturation (SpO2) accuracy validation comparing prototype pulse oximeter oxygen saturation measurements directly to arterial blood saturation during non-motion conditions over the range of 60-100% SaO2 as measured by Reference CO-Oximetry. Additionally, the prototype pulse oximeter pulse rate measurements will be compared to 3-lead ECG heart rate measurements made via a multi-parameter monitor.
Detailed description
The description of this study is to conduct an oxygen saturation (SpO2) accuracy validation comparing prototype pulse oximeter oxygen saturation measurements directly to arterial blood saturation during non-motion conditions over the range of 60-100% SaO2 as measured by Reference CO-Oximetry. Additionally, the prototype pulse oximeter pulse rate measurements will be compared to 3-lead ECG heart rate measurements made via a multi-parameter monitor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will be ten to fifteen male and female subjects of any race, ranging in pigmentation from light to dark to meet the study design requirements
Key inclusion criteria (6 listed)
- healthy
- non-smoking, or who have refrained from smoking for 2 days
- male or female of any race
- 18-45 years.
- Subjects must have the ability to understand and provide written informed consent as well as be willing to comply with study procedures.
Key exclusion criteria (12 listed)
- - morbid obesity (defined as BMI > 39.5),
- injuries, deformities or abnormalities or piercings that may prevent proper application of the device under test, compromised circulation,
- subjects with known respiratory conditions (smokers with COHb levels >3%, flu, pneumonia, bronchitis, shortness of breath/ respiratory distress, severe asthma, emphysema, COPD),
- subjects with known heart or cardiovascular conditions (uncontrolled hypertension, heart arrhythmias other than sinus arrhythmia, previous heart attack, blocked artery, history of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy, history of stroke, transient ischemic attack or carotid artery disease),
- 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.
Primary outcome
The OxiCable pulse rate measurement performance is an ARMS of 3 or better over the full range 60-100% SaO2.
Time frame: 2.5 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Individual participant dataSharing planned: Undecided. This study was cancelled.
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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.
David Ransom, MD principal investigator
Clinimark, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Medtronic - MITG 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 6 inclusion and 12 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: withdrawn, as of the sponsor's last update on 18 Oct 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The OxiCable pulse rate measurement performance is an ARMS of 3 or better over the full range 60-100% SaO2. (time frame: 2.5 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 18 Oct 2016.