Pulse Oximetry- Performance During Severe Signal Interference

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01720355
First received: October 31, 2012
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse subject population during severe signal interference over a specified saturation range.


Condition
Healthy Subjects

Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Covidien:

Primary Outcome Measures:
  • SpO2 Accuracy (percentage of blood oxygen saturation) [ Time Frame: 1.5 hours per subject ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy, well perfused

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
  Contacts and Locations
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

Locations
United States, Colorado
Covidien
Boulder, Colorado, United States, 80301
Sponsors and Collaborators
Covidien
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01720355     History of Changes
Other Study ID Numbers: COVMOPR0377
Study First Received: October 31, 2012
Last Updated: February 12, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 28, 2014