- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02247765
Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion
March 21, 2017 updated by: Medtronic - MITG
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Use an investigational oximetry system to evaluate the triggering of the "sensor off" status with marketed, off-the-shelf sensors.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Boulder, Colorado, United States, 80301
- Boulder Clinical Laboratory
-
Boulder, Colorado, United States, 80301
- Covidien RMS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arterial Line
CO-Oximetry value obtained as a comparator.
Obtained during motion conditions.
|
Arterial line is inserted to draw a CO-Oximeter value as it is the gold standard and as advised in ISO 80601
Other Names:
|
Experimental: Motion
The subject has to perform motions during the procedure.
This is to verify that device is able to read through motion.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 6 months
|
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.
|
up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric Heyer, MD, Medtronic - MITG
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
September 18, 2014
First Submitted That Met QC Criteria
September 23, 2014
First Posted (Estimate)
September 25, 2014
Study Record Updates
Last Update Posted (Actual)
May 5, 2017
Last Update Submitted That Met QC Criteria
March 21, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVMOPR0445
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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