N/A
N=27
Novel Non-Invasive Monitoring Parameter in Healthy Volunteers
No Conditions · Focus is Respiratory Rate
Bottom Line
View on ClinicalTrials.gov: NCT01294514 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device. — 13.2; 13.8; 19.5 Breaths Per Minute (BrPM)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device. |
13.2; 13.8; 19.5 | — |
| SECONDARY The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence. |
0.84 | — |
Summary
The purpose of this study is to study Non-Invasive Performance evaluation of monitoring algorithm.
Eligibility Criteria
Inclusion Criteria
- Subject is 18 or older
- Subject is willing and able to provide written consent
Exclusion Criteria
- Severe contact allergies to standard adhesive materials
- Subjects with abnormalities that may prevent proper application of the device
- Women who are pregnant or lactating
- Subjects with significant Arrhythmias
Data sourced from ClinicalTrials.gov (NCT01294514). 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.