Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly)
NCT ID: NCT01747460
Last Updated: 2013-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
25 participants
OBSERVATIONAL
2012-09-30
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
2. Unexplained syncopal episodes
3. Hypertension (defined as a systolic pressure of \>145 mmHg or a diastolic pressure \>90 mm Hg on three consecutive readings)
4. Premature ventricular contractions (PVC's) that are symptomatic or occur at a rate of more than 5/minute
5. History of seizures (except childhood febrile seizures) or epilepsy
6. Routine use of tranquilizers and/or excessive anxiety
7. History of frequent headaches or migraines
8. History of stroke
9. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test multiple sensors
10. 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)
11. History of significant respiratory disease, such as severe asthma, emphysema, etc.
12. Sickle cell disease or trait.
13. 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.
14. Abnormal ECG finding
15. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain)
16. Prior or known allergies to heparin.
17. History of transient ischemic attacks or carotid artery disease
18. History of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy
19. History of chronic renal impairment
20. History of recent arterial cannulation (less than 1 month prior to study)
21. History of complications from previous arterial cannulation
22. Current use of blood thinners
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic - MITG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Covidien
Boulder, Colorado, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COVMOPR0250
Identifier Type: -
Identifier Source: org_study_id