N/A
N=90
Respiration Rate V2.0 in a Hospital Setting
Respiratory Rate
Bottom Line
View on ClinicalTrials.gov: NCT01837537 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor — -0.82 BrPM (breaths per minute)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor |
-0.82 | — |
| SECONDARY Mean Error (ME) +/- 1 Breath Per Minute, Max-N Sensor |
-0.16 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01837537). 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.