Novel Non-Invasive Monitoring Parameter in a Hospital Setting

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

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

Official Title
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A Novel Cardio-Respiratory Parameter in a Hospital Setting

Conditions
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Respiratory Insufficiency, Respiratory Failure

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| In-patient Volunteers<br>In-patients from the hospital who choose to participate in the study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Participants were monitored for average of 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Participants were monitored on average for 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hospital Setting