Novel Non-Invasive Monitoring Parameter in Healthy Volunteers
The purpose of this study is to study Non-Invasive Performance evaluation of monitoring algorithm.
Focus is Respiratory Rate
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Novel Cardio-Respiratory Parameter in Healthy Volunteers|
- 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 ] [ Designated as safety issue: No ]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.
- 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. [ Time Frame: Participants were monitored on average of 30 minute periods ] [ Designated as safety issue: No ]
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
|Study Start Date:||February 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Healthy volunteers ASA Class 1
Assess equivalency, performance, and accuracy of a new monitoring algorithm in Healthy Volunteers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294514
|United States, Colorado|
|Boulder, Colorado, United States, 80301|
|Principal Investigator:||Scott Kelley, MD||Covidien|