Novel Non-Invasive Monitoring Parameter in Healthy Volunteers
Novel Cardio-Respiratory Parameter in Healthy Volunteers
1 other identifier
observational
27
1 country
1
Brief Summary
The purpose of this study is to study Non-Invasive Performance evaluation of monitoring algorithm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 11, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
January 10, 2013
CompletedAugust 7, 2014
August 1, 2014
Same day
February 10, 2011
May 2, 2012
August 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
Participants were monitorerd on average of 30 minute period
Secondary Outcomes (1)
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
Study Arms (1)
Healthy Volunteers
Healthy volunteers ASA Class 1
Eligibility Criteria
Healthy Volunteers
You may qualify if:
- Subject is 18 or older
- Subject is willing and able to provide written consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (1)
Covidien- RMS
Boulder, Colorado, 80301, United States
Results Point of Contact
- Title
- Ulf Borg, Director of Clinical Affairs
- Organization
- Covidien
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Kelley, MD
Medtronic - MITG
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2011
First Posted
February 11, 2011
Study Start
February 1, 2011
Primary Completion
February 1, 2011
Study Completion
March 1, 2012
Last Updated
August 7, 2014
Results First Posted
January 10, 2013
Record last verified: 2014-08