Focus is Respiratory Rate, No Conditions
Conditions
Keywords
Respiratory Rate
Brief summary
The purpose of this study is to study Non-Invasive Performance evaluation of monitoring algorithm.
Detailed description
Assess equivalency, performance, and accuracy of a new monitoring algorithm in Healthy Volunteers.
Interventions
None listed
Sponsors
Medtronic - MITG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject is 18 or older * Subject is willing and able to provide written consent
Exclusion criteria
* Severe contact allergies to standard adhesive materials * Subjects with abnormalities that may prevent proper application of the device * Women who are pregnant or lactating * Subjects with significant Arrhythmias
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Participants were monitorerd on average of 30 minute period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Participants were monitored on average of 30 minute periods | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Volunteers Healthy volunteers were studied | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Excluded due to Arrhythmia | 1 |
Baseline characteristics
| Characteristic | Healthy Volunteers |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age, Continuous | 35 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
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.
Time frame: Participants were monitorerd on average of 30 minute period
Population: One participant was excluded from the analysis based on cardiac arrhythmia
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respiration Rate From Covidien Respiration Rate Software | 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. | 13.2 Breaths Per Minute (BrPM) | Standard Deviation 3 |
| Respiration Rate From Endtidal Carbon Dioxide | 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. | 13.8 Breaths Per Minute (BrPM) | Standard Deviation 3.2 |
| 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. | 19.5 Breaths Per Minute (BrPM) | Standard Deviation 9.4 |
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
Time frame: Participants were monitored on average of 30 minute periods
Population: One participant was excluded from the data analysis based on cardiac arrhythmia
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Respiration Rate From Covidien Respiration Rate Software | 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. | 0.84 Breaths Per Minute (BrPM) |
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.
Time frame: Overall average
Population: One participant was excluded from the data analysis based on cardiac arrhythmia
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respiration Rate From Covidien Respiration Rate Software | Calculate Covidien Respiration Rate Software Accuracy as Mean Error +/- Standard Deviation | 0.37 Breaths Per Minute (BrPM) | Standard Deviation 0.78 |