Novel Cardio-Respiratory Parameter in Healthy Volunteers

Medtronic - MITG1 site in 1 country27 target enrollmentFebruary 2011

ConditionsNo Conditions Focus is Respiratory Rate

Overview

Phase: N/A
Intervention: Not specified
Conditions: No Conditions
Sponsor: Medtronic - MITG
Enrollment: 27
Locations: 1
Primary Endpoint: The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to study Non-Invasive Performance evaluation of monitoring algorithm.

Detailed Description

Assess equivalency, performance, and accuracy of a new monitoring algorithm in Healthy Volunteers.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

March 2012

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medtronic - MITG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is 18 or older
•Subject is willing and able to provide written consent

Exclusion Criteria

•Severe contact allergies to standard adhesive materials
•Subjects with abnormalities that may prevent proper application of the device
•Women who are pregnant or lactating
•Subjects with significant Arrhythmias

Outcomes

Primary Outcomes

The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.

Time Frame: Participants were monitorerd on average of 30 minute period

Mean and standard deviations of respiration rates collected from healthy volunteers were compared between Covidien Respiration Rate Software, Transthoracic Impedance and Overscored End-Tidal Carbon Dioxide Waveforms. Each volunteer served as its own control.

Secondary Outcomes

The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.(Participants were monitored on average of 30 minute periods)