An observational study in Respiratory Insufficiency and Respiratory Failure, sponsored by Medtronic - MITG. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-07.
Sponsored by Medtronic - MITG · Observational
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 63 is below the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Medtronic - MITG is the lead sponsor of 176 studies on the registry; 5 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
General Care Floor Patients
Exclusion Criteria:
In-patients from the hospital who choose to participate in the study
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
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
Recruitment dates were February 10, 2011- to March 4th,2011
| Milestone | Respiration Rate in GCF Patients |
|---|---|
| Started | 63 |
| Completed | 53 |
| Not completed | 10 |
| Withdrew: Arrhythmia | 4 |
| Withdrew: Files could not be processed | 3 |
| Withdrew: Files unreadable | 3 |
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.
| BrPM (Breaths Per Minute) | Respiration Rate From Covidien Respiration Rate Software | Respiration Rate From Endtidal Carbon Dioxide Waveform | Respiration Rate From Transthoracic Impedance |
|---|---|---|---|
| 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. | 15.4 ± 4.0 | 16.0 ± 4.6 | 16.8 ± 4.8 |
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
| Breaths Per Minute (BrPM) | Overall Study Population |
|---|---|
| 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. | 1.60 |
| Breaths Per Minute (BrPM) | In-patient Volunteers |
|---|---|
| Calculate Covidien Respiration Rate Software Accuracy as Mean Error +/- Standard Deviation. | 0.07 ± 1.98 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| In-patient Volunteers | — | 0/63 (0%) | 0/63 (0%) |
| Age, Categorical(Participants) | In-patient Volunteers |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 57 |
| >=65 years | 6 |
| Age, Continuous(years) | In-patient Volunteers |
|---|---|
| Mean | 47 ± 15 |
| Sex: Female, Male(Participants) | In-patient Volunteers |
|---|---|
| Female | 40 |
| Male | 23 |
| Region of Enrollment(participants) | In-patient Volunteers |
|---|---|
| United States | 63 |
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Medtronic - MITG