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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Healthy volunteers ASA Class 1 |
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| 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 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. | Participants were monitorerd on average of 30 minute period |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy Volunteers
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| Name | Affiliation | Role |
|---|---|---|
| Scott Kelley, MD | Medtronic - MITG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covidien- RMS | Boulder | Colorado | 80301 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Respiration Rate in Healthy Volunteers | Healthy volunteer participants were monitored for 30 minute period to collect respiratory rate information from non-invasive sensors. Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Healthy volunteers
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers | Healthy volunteers were studied |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One participant was excluded from the analysis based on cardiac arrhythmia | Posted | Mean | Standard Deviation | Breaths Per Minute (BrPM) | Participants were monitorerd on average of 30 minute period |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteers | A selection of subjects from the general population from ages 18 - 50. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ulf Borg, Director of Clinical Affairs | Covidien | 303 305 2400 | ulf.borg@covidien.com |
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| Participants were monitored on average of 30 minute periods |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Respiration Rate From Endtidal Carbon Dioxide |
Respiration Rate determined by manual overscoring of capnography waveforms. |
| OG002 | Respiration Rate From Transthoracic Impedance | Respiration Rate determined by Transthoracic Impedance |
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| Secondary | 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 | One participant was excluded from the data analysis based on cardiac arrhythmia | Posted | Number | Breaths Per Minute (BrPM) | Participants were monitored on average of 30 minute periods |
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| Post-Hoc | Calculate Covidien Respiration Rate Software Accuracy as Mean Error +/- Standard Deviation | The Covidien Nellcor Respiration Rate Software shall calculate respiration rate as mean error of +/- standard deviation. | One participant was excluded from the data analysis based on cardiac arrhythmia | Posted | Mean | Standard Deviation | Breaths Per Minute (BrPM) | Overall average |
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| 0 |
| 27 |
| 0 |
| 27 |
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