Bedside Respiratory Patient Monitoring System - Sensor Off Study

NCT ID: NCT02075346

Last Updated: 2014-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2013-11-30

Brief Summary

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Use of an investigational oximetry system to evaluate the triggering of the "sensor off" status with the marketed off-the-shelf sensors.

Detailed Description

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The Multi-functional Patient Monitoring PCBA is an electronic circuit board in the monitoring system that performs calculations.

The study will evaluate the performance of the Sensor Off New Patient Monitoring system by exposing the sensor to an ambient light source, sensor slipping off the finger with the light emitter and detector facing each other or a sensor slipping off under a blanket.

Conditions

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Healthy Volunteers

Study Design

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Observational Model Type

CASE_ONLY

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects 18 years 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Kelley, MD

Role: PRINCIPAL_INVESTIGATOR

Medtronic - MITG

Locations

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Boulder Clinical Laboratory

Boulder, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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COVMOPR0419

Identifier Type: -

Identifier Source: org_study_id

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