N/A
N=63
Novel Non-Invasive Monitoring Parameter in a Hospital Setting
Respiratory Insufficiency · Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT01306201 ↗Enrolled (actual)
63
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. — 15.4; 16.0; 16.8 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
- Mar 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. |
15.4; 16.0; 16.8 | — |
| 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. |
1.60 | — |
Summary
Data collected from this study will be used to evaluate the performance of a monitoring algorithm.
Eligibility Criteria
Inclusion Criteria
- Subjects 18 years old or older
- Written informed consent from the patient or their legally authorized representative before initiation of any study-related procedures
- Subjects on general care floor
Exclusion Criteria
- Severe contact allergies to standard adhesive materials
- Abnormalities that may prevent proper application of the device
- Women who are pregnant or lactating
- Subjects with significant arrhythmia
Data sourced from ClinicalTrials.gov (NCT01306201). 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.