Novel Non-Invasive Monitoring Parameter in a Hospital Setting

Medtronic - MITG63 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Respiratory Insufficiency Respiratory Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects 18 years old or older 2. Written informed consent from the patient or their legally authorized representative before initiation of any study-related procedures 3. Subjects on general care floor Exclusion Criteria: 1. Severe contact allergies to standard adhesive materials 2. Abnormalities that may prevent proper application of the device 3. Women who are pregnant or lactating 4. Subjects with significant arrhythmia

Locations (2)

The University of Colorado Health Sciences Center (UCHSC)

Denver, Colorado, United States

The Ohio State University Medical Center (OSUMC)

Columbus, Ohio, 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 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.

Time frame: Participants were monitored for average of 30 minutes

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 for 30 minutes

Data from ClinicalTrials.gov

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