Clinical trial NCT01747473: Pulse Oximetry_Performance During Severe Signal Interference - PCBA-1 (Printed Circuit Board Assembly)
Official title: Controlled Acute Hypoxia Studies Comparing Pulse Oximetry to Arterial Blood Samples During Motion in Healthy, Well-perfused Subjects With the Functional Monitoring PCBA-1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Subjects
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2012-12-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Well perfused

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.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects between the ages of 18 to 50 years (inclusive).
2. 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
3. All female volunteers must have a negative urine pregnancy test prior to participation.

Exclusion Criteria:

1. A room-air baseline % modulation \< 1.5% on all four fingers on the test hand
2. Pregnancy or lactating women
3. History of syncopal episodes
4. Hypertension (defined as a systolic pressure of \>145 mmHg or a diastolic pressure \>90 mm Hg on three consecutive readings)
5. Premature ventricular contractions (PVC's) that are symptomatic or occur at a rate of more than 5/minute
6. History of seizures (except childhood febrile seizures) or epilepsy
7. Routine use of tranquilizers and/or excessive anxiety
8. History of frequent headaches or migraines
9. History of stroke
10. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test multiple sensors
11. 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)
12. History of significant respiratory disease, such as severe asthma, emphysema, etc.
13. Sickle cell disease or trait.
14. 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.
15. 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.
16. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain)
17. Prior or known allergies to heparin
18. History of transient ischemic attacks or carotid artery disease
19. History of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy
20. History of chronic renal impairment
21. History of recent arterial cannulation (less than 1 month prior to study)
22. History of complications from previous arterial cannulation
23. Current use of blood thinners

Primary outcomes:
measure: SpO2 Accuracy (percentage of blood oxygen saturation)
timeFrame: Duration of subject visit- approx. 1.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Covidien
state: Colorado
Study officials:
References: