Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Device: Nellcor USB Pulse Oximeter Monitor Interface Cable

• Registration Number: NCT02265783
• Lead Sponsor: Medtronic - MITG

Brief Summary

The purpose of this study is to validate that the device posts a Sensor-Off message within the time frame stated in the proposed claims.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-03
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-16
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2017-03
• Results First Submitted: 2017-03-21
• Results First Submitted QC: 2017-03-21
• Last Update Submitted: 2017-03-21
• Results First Posted: 2017-05-01
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

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

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nellcor USB Pulse Oximeter Monitor Interface Cable Sensor Test	Nellcor USB Pulse Oximeter Monitor Interface Cable	-

Primary Outcome Measures

Name	Time	Method
Report the Time Until the Device Posts "Sensor Off" After the Sensor is Removed	1 minute per event, multiple events per subject. Total duration up to 1 hour	A series of sensor-off events were collected from subjects in the study using marketed, off-the-shelf sensors. Each event was marked as pass if event duration (Timeend - Timestart) was less than or equal to 60 seconds; otherwise, the event was marked as greater than or equal to 60 seconds. The acceptance criteria is if 90% of the time the product posts Sensor Off, or any equal or higher priority alarm, within 60 seconds after sensor is removed.

Trial Locations

Locations (1)

Boulder Clinical Laboratory; 🇺🇸 Boulder, Colorado, United States