NCT01294514CompletedNot Applicable
Novel Cardio-Respiratory Parameter in Healthy Volunteers
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medtronic - MITG
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
The purpose of this study is to study Non-Invasive Performance evaluation of monitoring algorithm.
Detailed Description
Assess equivalency, performance, and accuracy of a new monitoring algorithm in Healthy Volunteers.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
Time Frame: Participants were monitorerd on average of 30 minute period
Mean and standard deviations of respiration rates collected from healthy volunteers were compared between Covidien Respiration Rate Software, Transthoracic Impedance and Overscored End-Tidal Carbon Dioxide Waveforms. Each volunteer served as its own control.
Secondary Outcomes
- 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.(Participants were monitored on average of 30 minute periods)
Investigators
Study Sites (1)
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