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

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Medtronic

Status

Completed

Conditions

Healthy

Study type

Observational

Funder types

Industry

Identifiers

NCT01747473
COVMOPR0384

Details and patient eligibility

About

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

Enrollment

17 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • A room-air baseline % modulation < 1.5% on all four fingers on the test hand
  • Pregnancy or lactating women
  • History of 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.
  • 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.
  • 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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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