Focus of the Study is Measuring 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 healthy volunteer population when compared to established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR) (CO2).
Detailed description
Volunteer subjects with no significant medical problems (see specific inclusion/exclusion criteria) over the age of 18, male and female, who provide written informed consent prior to the procedure, are not pregnant, and without any contact skin allergies to adhesives found in standard pulse oximetry sensors. The study consists of measuring parameters related to respiration in healthy volunteers by means of the Bedside Respiratory Patient Monitoring System with RR V2.0 (Nightingale). The prototype 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
Yes
Inclusion criteria
* Male or female subjects. * 18 years or older. * Subject is willing and able to provide written consent.
Exclusion criteria
* Subject is younger than 18. * Subject is pregnant or lactating * 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 continous monitoring | The software shall calculate respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ME +/- 1 Breath Per Minute, Max-N Sensor | up to 40 minutes of continuous monitoring | The software shall calculate respiration rate values via Max-N with a mean error of +/- 1 breath per minute relative to a capnography based reference. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| no Treatment no treatment, prospective observational | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | no Treatment |
|---|---|
| Age, Continuous | 32.9 years STANDARD_DEVIATION 6.97 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 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 | 27 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor
The software shall calculate respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference.
Time frame: up to 40 minutes of continous monitoring
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| no Treatment | Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor | -0.05 BrPM | Standard Deviation 1.04 |
Secondary
ME +/- 1 Breath Per Minute, Max-N Sensor
The software shall calculate respiration rate values via Max-N with a mean error of +/- 1 breath per minute relative to a capnography based reference.
Time frame: up to 40 minutes of continuous monitoring
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| no Treatment | ME +/- 1 Breath Per Minute, Max-N Sensor | -0.03 BrPM | Standard Deviation 1.05 |