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

NCT02247765 | Completed Phase 3 Results

• 1 other identifier: COVMOPR0445
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy; Hypoxia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  up to 6 months

Study Arms (2)

Arterial Line

EXPERIMENTAL

CO-Oximetry value obtained as a comparator. Obtained during motion conditions.

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.

Device: Motion

Interventions

Arterial line DEVICE

Arterial line is inserted to draw a CO-Oximeter value as it is the gold standard and as advised in ISO 80601

Also known as: CO-Oximeter SaO2 value

Arterial Line

Motion DEVICE

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.

Motion

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female of any race
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (2)

Boulder Clinical Laboratory

Boulder, Colorado, 80301, United States

Location

Covidien RMS

Boulder, Colorado, 80301, United States

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Vascular Access Devices

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Results Point of Contact

• Title: Michael Luna-Victoria
• Organization: Medtronic

michael.luna-victoria@medtronic.com

3034068955

Study Officials

• Eric Heyer, MD

  Medtronic - MITG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 25, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 5, 2017
• Results First Posted: May 5, 2017

Record last verified: 2017-03

Locations

US (2)