Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly)

Completed

Conditions studied: Healthy

In brief

To determine accuracy specifications of the Pulse oximeter.

Key facts

Study ID

NCT01747460

Run by

Medtronic - MITG

People needed

25

Starts

2012-09-01

Expected to finish

2012-12-01

Last updated by the study team

2013-12-06

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pregnancy or lactating women
• Unexplained 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.
• Abnormal ECG finding
• 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

Where it is running

• Covidien — Boulder, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.