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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720355
|Boulder, Colorado, United States, 80301 |
Medtronic - MITG
ClinicalTrials.gov processed this record on March 23, 2017
||Medtronic - MITG
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 31, 2012
||February 12, 2013