Pulse Oximetry- Performance During Severe Signal Interference
This study has been completed.
Information provided by (Responsible Party):
Medtronic - MITG
First received: October 31, 2012
Last updated: February 12, 2013
Last verified: February 2013
Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse subject population during severe signal interference over a specified saturation range.
||Time Perspective: Prospective
Primary Outcome Measures:
- SpO2 Accuracy (percentage of blood oxygen saturation) [ Time Frame: 1.5 hours per subject ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2012 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 50 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Healthy, well perfused
- 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.
- 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
- Current use of blood thinners
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01720355
|Boulder, Colorado, United States, 80301 |
Medtronic - MITG
ClinicalTrials.gov processed this record on September 21, 2017
||Medtronic - MITG
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 31, 2012
||February 12, 2013