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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-patient Volunteers | In-patients from the hospital who choose to participate in the study |
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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 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 |
| 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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General Care Floor Patients
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| Name | Affiliation | Role |
|---|---|---|
| Sergio Bergese, MD | The Ohio State Medical Center, Dept of Anesthesia | Principal Investigator |
| Robert McIntyre, MD | University of Colorado Denver, School of Medicine dept of Surgery Division of GI, Tumor and Endocrine Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Colorado Health Sciences Center (UCHSC) | Denver | Colorado | 80262 | United States | ||
| The Ohio State University Medical Center (OSUMC) |
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Recruitment dates were February 10, 2011- to March 4th,2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Respiration Rate in GCF Patients | In-patients from the hospital general care floor, who choose to participate in the study. Participants were monitored for 30 minute periods to collect respiratory rate information from non-invasive sensors. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | In-patient Volunteers | In-patients from the hospital who choose to participate in the study |
| Units | Counts |
|---|---|
| Participants |
|
| 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 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. | 10 participants were excluded from data analysis due to following reasons: unreadable files,arrhythmia,electronic data files coud not be processed | Posted | Mean | Standard Deviation | BrPM (Breaths Per Minute) | Participants were monitored for average of 30 minutes |
|
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 | In-patient Volunteers | In-patients from the hospital who choose to participate in the study |
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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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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Participants were monitored on average for 30 minutes |
| Columbus |
| Ohio |
| 43210 |
| United States |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Respiration Rate From Endtidal Carbon Dioxide Waveform | Respiration rate determined by manual overscoring of capnography waveforms |
| OG002 | Respiration Rate From Transthoracic Impedance | Respiration Rate derived from 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 | Posted | Number | Breaths Per Minute (BrPM) | Participants were monitored on average for 30 minutes |
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|
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| Post-Hoc | Calculate Covidien Respiration Rate Software Accuracy as Mean Error +/- Standard Deviation. | Posted | Mean | Standard Deviation | Breaths Per Minute (BrPM) | Overall average |
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| 0 |
| 63 |
| 0 |
| 63 |
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