Pulse Oximetry- Performance During Severe Signal Interference | NCT01720355 | Trialant
CompletedObservationalUpdated Feb 13, 2013
Pulse Oximetry- Performance During Severe Signal Interference
ClinicalTrials.gov ID
NCT01720355
Lead Sponsor
Medtronic - MITGINDUSTRY
Overall Status
Completed
Study Type
Observational
Enrollment
17Actual
Last Update Posted
Feb 13, 2013Estimated
Start Date
Aug 2012
Primary Completion Date
Nov 2012Actual
Completion Date
Nov 2012Actual
Brief Summary
Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse subject population during severe signal interference over a specified saturation range.
Healthy Subjects
No interventions
There are no interventions for this study.
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
Male or female subjects between the ages of 18 to 50 years (inclusive).
Must undergo a physical examination by a licensed physician, advanced practice nurse or physician assistant, including a 12 lead ECG, a medical history, and a blood test checking complete blood count and screening for sickle cell trait or disease
All female volunteers must have a negative urine pregnancy test prior to participation.
Exclusion Criteria:
A room-air baseline % modulation < 1.5% on all four fingers on the test hand
Pregnancy or lactating women
History of syncopal episodes
Hypertension (defined as a systolic pressure of >145 mmHg or a diastolic pressure >90 mm Hg on three consecutive readings)
Premature ventricular contractions (PVC's) that are symptomatic or occur at a rate of more than 5/minute
History of seizures (except childhood febrile seizures) or epilepsy
Routine use of tranquilizers and/or excessive anxiety
History of frequent headaches or migraines
History of stroke
Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test multiple sensors
History of "altitude sickness" defined as headaches, malaise or dizziness when in the mountains or in an aircraft at altitude significantly above sea level for a prolonged period of time (> 1 hour)
History of significant respiratory disease, such as severe asthma, emphysema, etc.
Sickle cell disease or trait.
The use of medications, pre-existing medical conditions, treatment for a medical condition or any other reason deemed relevant by the clinician conducting the study.
A clinically significant abnormal finding on medical history, physical examination, clinical laboratory test or ECG. Clinical significance will be assessed by the principal investigator or designee.
Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain)
Prior or known allergies to heparin
History of transient ischemic attacks or carotid artery disease
History of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy
History of chronic renal impairment
History of recent arterial cannulation (less than 1 month prior to study)
History of complications from previous arterial cannulation