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Accuracy Validation of a Pulse Oximetry Monitor

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ClinicalTrials.gov Identifier: NCT02506010
Recruitment Status : Withdrawn (Sponsor decided not to run this study.)
First Posted : July 22, 2015
Last Update Posted : October 18, 2016
Sponsor:
Collaborator:
Clinimark, LLC
Information provided by (Responsible Party):
Medtronic - MITG

Brief 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. Additionally, the prototype pulse oximeter pulse rate measurements will be compared to 3-lead ECG heart rate measurements made via a multi-parameter monitor.

Condition or disease
Healthy

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 Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SpO2 Accuracy Validation of a USB Pulse Oximetry Monitor Interface Cable Via Reference Co-Oximetry
Study Start Date : November 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • - 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,
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506010


Locations
United States, Colorado
Clinimark
Louisville, Colorado, United States, 80027
Sponsors and Collaborators
Medtronic - MITG
Clinimark, LLC
Investigators
Principal Investigator: David Ransom, MD Clinimark, LLC

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT02506010     History of Changes
Other Study ID Numbers: COVMOPR0499
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This study was cancelled.

Keywords provided by Medtronic - MITG:
Hypoxia