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

Phase 3

Completed

• Conditions: Healthy; Hypoxia

• Registration Number: NCT02247765
• Lead Sponsor: Medtronic - MITG

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 Timeline

• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-09-23
• Study First Posted: 2014-09-25
• Study Start: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Results First Submitted: 2016-02-15
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-21
• Last Update Submitted: 2017-03-21
• Results First Posted: 2017-05-05
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
SpO2 Accuracy During Motion Conditions - MaxA Sensor	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	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.

Trial Locations

Locations (2)

Boulder Clinical Laboratory; 🇺🇸 Boulder, Colorado, United States

Covidien RMS; 🇺🇸 Boulder, Colorado, United States