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OpenTrials
Completed

NCT Number: NCT01720355

Pulse Oximetry- Performance During Severe Signal Interference

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

Completed

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Covidien

Boulder, Colorado, 80301, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. SpO2 Accuracy (percentage of blood oxygen saturation)

    Time frame: 1.5 hours per subject

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 2, 2012
Registry last updated
Feb 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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