Respiratory Failure, Respiratory Insufficiency
Conditions
Keywords
Hospital Setting
Brief summary
Data collected from this study will be used to evaluate the performance of a monitoring algorithm.
Detailed description
The goal of this study is to assess equivalency, performance, and accuracy of a new monitoring algorithm in a hospital setting.
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
No
Inclusion criteria
1. Subjects 18 years old or older 2. Written informed consent from the patient or their legally authorized representative before initiation of any study-related procedures 3. Subjects on general care floor
Exclusion criteria
1. Severe contact allergies to standard adhesive materials 2. Abnormalities that may prevent proper application of the device 3. Women who are pregnant or lactating 4. Subjects with significant arrhythmia
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 monitored for average of 30 minutes | 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. |
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 for 30 minutes | 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
Recruitment details
Recruitment dates were February 10, 2011- to March 4th,2011
Participants by arm
| Arm | Count |
|---|---|
| In-patient Volunteers In-patients from the hospital who choose to participate in the study | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Arrhythmia | 4 |
| Overall Study | Files could not be processed | 3 |
| Overall Study | Files unreadable | 3 |
Baseline characteristics
| Characteristic | In-patient Volunteers |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants |
| Age, Continuous | 47 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 63 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 63 |
| serious Total, serious adverse events | 0 / 63 |
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 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
Population: 10 participants were excluded from data analysis due to following reasons: unreadable files,arrhythmia,electronic data files coud not be processed
| 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. | 15.4 BrPM (Breaths Per Minute) | Standard Deviation 4 |
| Respiration Rate From Endtidal Carbon Dioxide Waveform | 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. | 16.0 BrPM (Breaths Per Minute) | Standard Deviation 4.6 |
| 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. | 16.8 BrPM (Breaths Per Minute) | Standard Deviation 4.8 |
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 for 30 minutes
| 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. | 1.60 Breaths Per Minute (BrPM) |
Post Hoc
Calculate Covidien Respiration Rate Software Accuracy as Mean Error +/- Standard Deviation.
Time frame: Overall average
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respiration Rate From Covidien Respiration Rate Software | Calculate Covidien Respiration Rate Software Accuracy as Mean Error +/- Standard Deviation. | 0.07 Breaths Per Minute (BrPM) | Standard Deviation 1.98 |