A Novel Cardio-Respiratory Parameter in a Hospital Setting

Medtronic - MITG2 sites in 1 country63 target enrollmentFebruary 2011

ConditionsRespiratory Insufficiency Respiratory Failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Respiratory Insufficiency
Sponsor: Medtronic - MITG
Enrollment: 63
Locations: 2
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

Data collected from this study will be used to evaluate the performance of a monitoring algorithm.

Detailed Description

The goal of this study is to assess equivalency, performance, and accuracy of a new monitoring algorithm in a hospital setting.

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

•Subjects 18 years old or older
•Written informed consent from the patient or their legally authorized representative before initiation of any study-related procedures
•Subjects on general care floor

Exclusion Criteria

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

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 monitored for average of 30 minutes

Mean and standard deviations of respiration rates collected from patients in the hospital settings were compared between Covidien Respiration Rate Software, Transthoracic Impedance and End-Tidal Carbon Dioxide Waveforms. Each patient 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 for 30 minutes)