Novel Non-Invasive Monitoring Parameter in Healthy Volunteers

N/ACompletedNCT01294514

Medtronic - MITG27 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

No Conditions Focus is Respiratory Rate

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Covidien- RMS

Boulder, Colorado, United States

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.

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.

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

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.

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

Time frame: Participants were monitored on average of 30 minute periods

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.