HealthyNCT02216344
Controlled Acute Hypoxia Study - Abbreviated Sensor Line
An observational study of Healthy and Hypoxia, run by Medtronic - MITG at 1 site in United States.
Trial summary
The primary objective of the study is to validate the proposed claims for the OxiCable device, for pulse rate and saturation accuracy in a diverse subject population over a specified saturation range. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Sep 2014
- 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: Up to 20 subjects recruited from the Clinical Laboratory subject data base.
Who may be able to join
- Male or female of any race
- 18-50 years old, inclusive
- Females: negative urine pregnancy test on the day of study participation (prior to exposure to hypoxia)
- Completed within the last year: physical exam by a licensed physician, physician assistant (PA), or advanced practice nurse; including a 12 lead ECG, a medical history, and blood test (complete blood count and sickle cell trait/disease screening)
- Meets specific demographic requirements for the monitoring device under study
- Willing and able to provide written informed consent
- Able to participate for the duration of the evaluation
Who cannot join
- Under 18 years or over 50 years of age
- Pregnant and/or lactating women
- Hypertension: on three consecutive readings, systolic pressure greater than 145 mm Hg or diastolic pressure greater than 90 mm Hg
- Premature ventricular contractions (PVCs) that are symptomatic or occur at a rate of more than four per minute
- History of seizures (except childhood febrile seizures) or epilepsy
- History of unexplained syncope
Show all 24Show fewer
- Daily or more frequent use of anxiolytic drugs (benzodiazepines) for treatment of anxiety disorder
- Recent history of frequent migraine headaches: average of two or more per month over the last year
- Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test site needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
- History of acute altitude sickness at or below moderate elevation (up to 5,000-10,000 feet) defined as three or more of the following symptoms: moderate to severe headache, general malaise, dizziness/lightheadedness, nausea/vomiting, fatigue/weakness, shortness of breath, nosebleed, persistent rapid pulse, or peripheral edema
- History of significant respiratory disease such as severe asthma or emphysema
- Sickle cell disease or trait
- Clinically significant abnormal finding on medical history, physical examination, clinical laboratory test or ECG. Clinical significance will be assessed by the principal investigator or study physician as designated.
- History of stroke, transient ischemic attack or carotid artery disease
- History of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy
- History of chronic renal impairment
- 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 from test digit(s)
- Unwillingness or inability to give informed consent
- 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
- Current use of blood thinners: prescription or daily aspirin use
Trial locations and contacts
1 site in 1 country.
United States1 site
Boulder Clinical Laboratory
Boulder, Colorado, 80301
About this study
Official title: Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples Using the Abbreviated Sensor Line in Healthy Subjects With the USB Pulse Oximetry Monitor Interface Cable
The primary objective of the study is to validate the proposed claims for the OxiCable device, for pulse rate and saturation accuracy in a diverse subject population over a specified saturation range.
Read the detailed description
The general procedure of invasive controlled hypoxia clinical studies is to directly compare test pulse oximeter measurements to saturation measurements made by a multi-wavelength CO-oximeter taken from arterial blood samples from healthy human subjects. Following arterial cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject breathes while simultaneous measurements are recorded from the test pulse oximeters and arterial blood samples at targeted levels of saturation.
- Keywords
- Patient safety monitors
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pulse Oximeter (the device) | The pulse oximetry devices were placed on subjects per the protocol. The subjects underwent gradual hypoxia and the output of the devices under test was compared to the SaO2 value as measured by a CO-Oximeter (the reference value), as outlined by ISO 80601, to ensure that the devices meet the specified performance claims. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse oximetry measurements of saturation from the test device will be compared to CO-Oximetry measurements of arterial oxygen saturation to demonstrate that the test sensor meets the oxygen saturation accuracy specifications for SpO2.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2014
- Study completionSep 2014
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.
- 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
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric T Heyer, MD, Principal investigator, Medtronic - MITG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216344
- Sponsor's protocol ID
- COVMOPR0440
- Status last verified
- Sep 2016
- First submitted
- 12 Aug 2014
- Last updated
- 30 Sep 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 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples Using the Abbreviated Sensor Line in Healthy Subjects With the USB Pulse Oximetry Monitor Interface Cable
- ClinicalTrials.gov ID
- NCT02216344
- Acronym / sponsor ID
- COVMOPR0440
- Keywords
- Patient safety monitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Aug 2014 (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 primary objective of the study is to validate the proposed claims for the OxiCable device, for pulse rate and saturation accuracy in a diverse subject population over a specified saturation range.
Detailed description
The general procedure of invasive controlled hypoxia clinical studies is to directly compare test pulse oximeter measurements to saturation measurements made by a multi-wavelength CO-oximeter taken from arterial blood samples from healthy human subjects. Following arterial cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject breathes while simultaneous measurements are recorded from the test pulse oximeters and arterial blood samples at targeted levels of saturation.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulse Oximeter (the device) | – | –The pulse oximetry devices were placed on subjects per the protocol. The subjects underwent gradual hypoxia and the output of the devices under test was compared to the SaO2 value as measured by a CO-Oximeter (the reference value), as outlined by ISO 80601, to ensure that the devices meet the specified performance claims. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Up to 20 subjects recruited from the Clinical Laboratory subject data base.
Key inclusion criteria (7 listed)
- Male or female of any race
- 18-50 years old, inclusive
- Females: negative urine pregnancy test on the day of study participation (prior to exposure to hypoxia)
- Completed within the last year: physical exam by a licensed physician, physician assistant (PA), or advanced practice nurse; including a 12 lead ECG, a medical history, and blood test (complete blood count and sickle cell trait/disease screening)
- Meets specific demographic requirements for the monitoring device under study
Key exclusion criteria (24 listed)
- Under 18 years or over 50 years of age
- Pregnant and/or lactating women
- Hypertension: on three consecutive readings, systolic pressure greater than 145 mm Hg or diastolic pressure greater than 90 mm Hg
- Premature ventricular contractions (PVCs) that are symptomatic or occur at a rate of more than four per minute
- History of seizures (except childhood febrile seizures) or epilepsy
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
Pulse oximetry measurements of saturation from the test device will be compared to CO-Oximetry measurements of arterial oxygen saturation to demonstrate that the test sensor meets the oxygen saturation accuracy specifications for SpO2.
Time frame: up to 6 months
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 30 Sep 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.
Eric T Heyer, MD principal investigator
Medtronic - MITG
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 and Hypoxia, 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 7 inclusion and 24 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 30 Sep 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 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?
Pulse oximetry measurements of saturation from the test device will be compared to CO-Oximetry measurements of arterial oxygen saturation to demonstrate that the test sensor meets the oxygen saturation accuracy specifications for SpO2. (time frame: up to 6 months). 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 30 Sep 2016; AzTrials last refreshed its copy on 27 Oct 2026.