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Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion

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ClinicalTrials.gov Identifier: NCT02247765
Recruitment Status : Completed
First Posted : September 25, 2014
Results First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Tracking Information
First Submitted Date  ICMJE September 18, 2014
First Posted Date  ICMJE September 25, 2014
Results First Submitted Date  ICMJE February 15, 2016
Results First Posted Date  ICMJE May 5, 2017
Last Update Posted Date May 5, 2017
Study Start Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 23, 2014)
SpO2 Accuracy (percentage of blood oxygen saturation) [ Time Frame: 1 hour ]
SpO2 Accuracy (percentage of blood oxygen saturation)
Change History Complete list of historical versions of study NCT02247765 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion
Official Title  ICMJE 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
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy
  • Hypoxia
Intervention  ICMJE
  • Device: Arterial line
    Arterial line is inserted to draw a CO-Oximeter value as it is the gold standard and as advised in ISO 80601
    Other Name: CO-Oximeter SaO2 value
  • Device: 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.
Study Arms  ICMJE
  • Experimental: Arterial Line
    CO-Oximetry value obtained as a comparator. Obtained during motion conditions.
    Intervention: Device: Arterial line
  • Experimental: Motion
    The subject has to perform motions during the procedure. This is to verify that device is able to read through motion.
    Intervention: Device: Motion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2014)
18
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2014)
20
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02247765
Other Study ID Numbers  ICMJE COVMOPR0445
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic - MITG
Study Sponsor  ICMJE Medtronic - MITG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Heyer, MD Medtronic - MITG
PRS Account Medtronic - MITG
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP