An observational study in Respiratory Rate, sponsored by Medtronic - MITG. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-17.
Sponsored by Medtronic - MITG · Observational
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).
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.
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.
Volunteer subjects from a hospital setting on the general care floor or general surgical care floor
Exclusion Criteria:
no treatment, prospective observational
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
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
| Milestone | no Treatment |
|---|---|
| Started | 90 |
| Completed | 90 |
| Not completed | 0 |
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).
| BrPM (breaths per minute) | no Treatment |
|---|---|
| Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor | -0.82 ± 2.19 |
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.
| BrPM | no Treatment |
|---|---|
| Mean Error (ME) +/- 1 Breath Per Minute, Max-N Sensor | -0.16 ± 2.85 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| no Treatment | — | 0/90 (0%) | 0/90 (0%) |
| Age, Continuous(years) | no Treatment |
|---|---|
| Mean | 54.2 (18 to 91) |
| Sex: Female, Male(Participants) | no Treatment |
|---|---|
| Female | 40 |
| Male | 50 |
| Race (NIH/OMB)(Participants) | no Treatment |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 12 |
| White | 76 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | no Treatment |
|---|---|
| United States | 90 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Medtronic - MITG