We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu

Pulse Oximetry_Performance During Severe Signal Interference - PCBA-1 (Printed Circuit Board Assembly)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: December 11, 2012
Last Update Posted: December 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic - MITG
Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse subject population during severe signal interference over a specified saturation range.


Study Type: Observational
Study Design: Time Perspective: Prospective
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

Further study details as provided by Medtronic - MITG:

Primary Outcome Measures:
  • SpO2 Accuracy (percentage of blood oxygen saturation) [ Time Frame: Duration of subject visit- approx. 1.5 hours ]

Enrollment: 17
Study Start Date: November 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy Well perfused

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747473

United States, Colorado
Boulder, Colorado, United States, 80301
Sponsors and Collaborators
Medtronic - MITG
  More Information

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01747473     History of Changes
Other Study ID Numbers: COVMOPR0384
First Submitted: November 27, 2012
First Posted: December 11, 2012
Last Update Posted: December 6, 2013
Last Verified: December 2013

Keywords provided by Medtronic - MITG: