Novel Non-Invasive Monitoring Parameter in Healthy Volunteers

Completed

• Conditions: Focus is Respiratory Rate; No Conditions

• Registration Number: NCT01294514
• Lead Sponsor: Medtronic - MITG

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.

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-02
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Study Completion: 2012-03
• Results First Submitted: 2012-05-02
• Results First Submitted QC: 2012-12-07
• Results First Posted: 2013-01-10
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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	The data used for analysis consisted of multiple simultaneous measures of RR_TTI, RR_V1.0 and RR_EtCO2 for each subject. Given N sets of simultaneous RR values for each of P patients, the simultaneous RR values were used to calculate a pair of RMSD values for each subject.; The two RMSD values, RMSDRR_V1.0_vs_EtCO2, and RMSDTTI_vs_EtCO2, quantify the mean absolute difference in simultaneous estimates of respiratory rate between RR_V1.0 compared with RR_EtCO2 and RR_TTI compared with RR_EtCO2, respectively for the subjects with 95% confidence of mean ± 3.38 BrPM. The Measure type is Number and represents the RMSD of Covidien Nellcor Respiration Rate Software

Trial Locations

Locations (1)

Covidien- RMS; 🇺🇸 Boulder, Colorado, United States