Pulse Oximetry- Evaluating Sensor Off- PCBA-1

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT01791569
• Lead Sponsor: Medtronic - MITG

Brief Summary

To demonstrate that the sensor-off feature on the Pulse oximeter displays per specifications when the sensor is removed from the finger.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted: 2012-11-29
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-15
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-05
• Last Update Posted: 2013-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Male or female subjects 18 or older (inclusive).
2. Subject is able to participate for the duration of the study
3. Subject is willing to sign an informed consent

Exclusion Criteria

1. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors
2. Physiologic abnormalities that prevent proper application of a medical sensor and electrode
3. Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device posts Sensor Off within 1 minute after sensor is removed at least 90% of the time.	1-2 hours per subject

Trial Locations

Locations (1)

Covidien; 🇺🇸 Boulder, Colorado, United States