Respiratory Rate
Conditions
Brief summary
The purpose of this study is to meet the respiration rate accuracy specifications for the study pulse oximeter monitoring system (study device) in a hospitalized volunteer population when compared to established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR)(CO2).
Detailed description
Volunteer subjects from a hospital setting (see specific inclusion/exclusion criteria) over the age of 18, male and female, who provide written informed consent prior to the procedure, and are without any contact skin allergies to adhesives found in standard pulse oximetry sensors. A cross section of demographics - cardiovascular, respiratory, and metabolic type cases should be considered for a broad distribution of medical and surgical patients. The study consists of measuring parameters related to respiration in hospitalized volunteers by means of the Bedside Respiratory Patient Monitoring System with RR V2.0 (Nightingale). The production-equivalent Nightingale device and multiparameter reference devices will be attached to the subject via sensors, nasal cannulas and ECG leads and the information from all devices will be captured continuously for up to 40 minutes to allow for at least 30 minutes of artifact free data 30 minutes.
Interventions
None listed
Sponsors
Medtronic - MITG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female. * 18 years or older. * A patient at the study site on a General Care Floor or General Surgery Care Floor. * Subject is willing and able to provide written consent.
Exclusion criteria
* Subject is younger than 18. * Subject has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors. * Subject has an abnormality that may prevent proper application of the device. * Subject is in atrial fibrillation. * Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds. * Subject has an implanted pacemaker. * Subject is unwilling or unable to sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor | up to 40 minutes of continuous monitoring | The software calculates respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Error (ME) +/- 1 Breath Per Minute, Max-N Sensor | up to 40 minutes of continuous monitoring | The software calculates respiration rate values via the Max-N Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography). The error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the Max-N sensor minus the Respiration Rate calculated from capnography. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| no Treatment no treatment, prospective observational | 90 |
| Total | 90 |
Baseline characteristics
| Characteristic | no Treatment |
|---|---|
| Age, Continuous | 54.2 years |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 76 Participants |
| Region of Enrollment United States | 90 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 |
Outcome results
Primary
Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor
The software calculates respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography).
Time frame: up to 40 minutes of continuous monitoring
Population: 90 subjects were enrolled. Out of the 90 enrolled 75 yielded valid data. The remaining 15 subjects did not meet the predetermined data criteria (such as reference was too noisy, timing of observations could not be matched, etc.)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| no Treatment | Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor | -0.82 BrPM (breaths per minute) | Standard Deviation 2.19 |
Secondary
Mean Error (ME) +/- 1 Breath Per Minute, Max-N Sensor
The software calculates respiration rate values via the Max-N Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography). The error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the Max-N sensor minus the Respiration Rate calculated from capnography.
Time frame: up to 40 minutes of continuous monitoring
Population: 90 subjects were enrolled. Out of the 90 enrolled 75 yielded valid data. The remaining 15 subjects did not meet the predetermined data criteria (such as reference was too noisy, timing of observations could not be matched, etc.)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| no Treatment | Mean Error (ME) +/- 1 Breath Per Minute, Max-N Sensor | -0.16 BrPM | Standard Deviation 2.85 |