Controlled Acute Hypoxia Study - Abbreviated Sensor Line

NCT02216344 | Completed

• 1 other identifier: COVMOPR0440
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to validate the proposed claims for the OxiCable device, for pulse rate and saturation accuracy in a diverse subject population over a specified saturation range.

Conditions

Healthy; Hypoxia

Keywords

Patient safety monitors

Outcome Measures

Primary Outcomes (1)

• Pulse oximetry measurements of saturation from the test device will be compared to CO-Oximetry measurements of arterial oxygen saturation to demonstrate that the test sensor meets the oxygen saturation accuracy specifications for SpO2.

  up to 6 months

Study Arms (1)

Pulse Oximeter (the device)

The pulse oximetry devices were placed on subjects per the protocol. The subjects underwent gradual hypoxia and the output of the devices under test was compared to the SaO2 value as measured by a CO-Oximeter (the reference value), as outlined by ISO 80601, to ensure that the devices meet the specified performance claims.

Eligibility Criteria

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

Study Population

Up to 20 subjects recruited from the Clinical Laboratory subject data base.

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:

• 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
• Premature ventricular contractions (PVCs) 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 site 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
• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Boulder Clinical Laboratory

Boulder, Colorado, 80301, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

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

Study Officials

• Eric T Heyer, MD

  Medtronic - MITG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 13, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 30, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)