N/A
Completed N=30
Respiration Rate V2.0 in Healthy Volunteers
Focus of the Study is Measuring Respiratory Rate
Source: ClinicalTrials.gov NCT01804062 ↗
Enrolled (actual)
30
Serious AEs
—
Results posted
Aug 2015
Primary outcomePrimary: Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor — -0.05 BrPM
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor |
-0.05 | — |
| SECONDARY ME +/- 1 Breath Per Minute, Max-N Sensor |
-0.03 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01804062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.