Pulse Oximetry- Performance During Severe Signal Interference

Healthy Subjects Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720355
• Other study ID #: COVMOPR0377
• Status: Completed
• Phase: N/A
• First received: October 31, 2012
• Last updated: February 12, 2013
• Start date: August 2012
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Subjects

Locations

Country	Name	City	State
United States	Covidien	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpO2 Accuracy (percentage of blood oxygen saturation)		1.5 hours per subject	No