HealthyPhase 3NCT02247765
Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion
A Phase 3 study testing Arterial line and Motion in people with Healthy and Hypoxia, run by Medtronic - MITG at 2 sites in United States.
Trial summary
To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject population during motion over a specified saturation range. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Arterial line and Motion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2014to Dec 2014
- Phase
- Phase 3
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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
- A room-air baseline % modulation < 1.5% on all four fingers on the test hand
- 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
- Ventricular premature complexes (VPC's) that are symptomatic or occur at a rate of more than four per minute
- History of seizures (except childhood febrile seizures) or epilepsy
Show all 26Show fewer
- History of unexplained syncope
- 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 sites 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 or sleep apnea
- 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 or artificial nails 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
- History of bleeding disorders or personal history of prolonged bleeding from injury.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boulder Clinical Laboratory
Boulder, Colorado, 80301
Covidien RMS
Boulder, Colorado, 80301
About this study
Official title: Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion in Healthy, Well Perfused Subjects With the USB Pulse Oximetry Monitor Interface Cable
To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject population during motion over a specified saturation range.
Read the detailed description
Use an investigational oximetry system to evaluate the triggering of the "sensor off" status with marketed, off-the-shelf sensors.
- Being tested
- Arterial line, Motion
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial lineDevice
Also called CO-Oximeter SaO2 value
Arterial line is inserted to draw a CO-Oximeter value as it is the gold standard and as advised in ISO 80601
MotionDevice
The subject is asked to move their hand by either rubbing or tapping their fingers at a specified frequency and amplitude during portions of the hypoxic procedure.
| Study group | Role | What they receive |
|---|---|---|
| Arterial Line | Experimental | CO-Oximetry value obtained as a comparator. Obtained during motion conditions. Receives: Device: Arterial line |
| Motion | Experimental | The subject has to perform motions during the procedure. This is to verify that device is able to read through motion. Receives: Device: Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 Accuracy During Motion Conditions - MaxA Sensor
For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit.
Measured: up to 6 months
SpO2 Accuracy During Motion Conditions - MaxN Sensor
For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit.
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 posted25 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2014
- Study completionDec 2014
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.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Heyer, MD, Principal investigator, Medtronic - MITG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247765
- Sponsor's protocol ID
- COVMOPR0445
- Status last verified
- Mar 2017
- First submitted
- 18 Sep 2014
- Last updated
- 5 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. 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 During Motion in Healthy, Well Perfused Subjects With the USB Pulse Oximetry Monitor Interface Cable
- ClinicalTrials.gov ID
- NCT02247765
- Acronym / sponsor ID
- COVMOPR0445
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Posted 5 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject population during motion over a specified saturation range.
Detailed description
Use an investigational oximetry system to evaluate the triggering of the "sensor off" status with marketed, off-the-shelf sensors.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arterial Line | Experimental | Device: Arterial lineCO-Oximetry value obtained as a comparator. Obtained during motion conditions. |
| Motion | Experimental | Device: MotionThe subject has to perform motions during the procedure. This is to verify that device is able to read through motion. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 (26 listed)
- A room-air baseline % modulation < 1.5% on all four fingers on the test hand
- 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
- Ventricular premature complexes (VPC's) that are symptomatic or occur at a rate of more than four per minute
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 |
|---|---|---|
| Arterial lineAlso: CO-Oximeter SaO2 valueArterial line is inserted to draw a CO-Oximeter value as it is the gold standard and as advised in ISO 80601 | Device | Arterial Line |
| MotionThe subject is asked to move their hand by either rubbing or tapping their fingers at a specified frequency and amplitude during portions of the hypoxic procedure. | Device | Motion |
Primary outcome
SpO2 Accuracy During Motion Conditions - MaxA Sensor
Time frame: up to 6 months
For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit.
SpO2 Accuracy During Motion Conditions - MaxN Sensor
Time frame: up to 6 months
For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Heyer, MD principal investigator
Medtronic - MITG
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arterial line and Motion in people with Healthy and Hypoxia, run by Medtronic - MITG at 2 sites 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 26 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 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2017). 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?
SpO2 Accuracy During Motion Conditions - MaxA Sensor (time frame: up to 6 months). The study lists 2 primary outcomes in all. 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 5 May 2017.