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

NCT01747473 | Completed

• 1 other identifier: COVMOPR0384
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Subjects

Outcome Measures

Primary Outcomes (1)

• SpO2 Accuracy (percentage of blood oxygen saturation)

  Duration of subject visit- approx. 1.5 hours

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy Well perfused

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Covidien

Boulder, Colorado, 80301, United States

Location

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: December 11, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 6, 2013

Record last verified: 2013-12

Locations

US (1)