Novel Non-Invasive Monitoring Parameter in a Hospital Setting
A Novel Cardio-Respiratory Parameter in a Hospital Setting
1 other identifier
observational
63
1 country
2
Brief Summary
Data collected from this study will be used to evaluate the performance of a monitoring algorithm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2011
2 active sites
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
CompletedFirst Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 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
28 days
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 patients in the hospital settings were compared between Covidien Respiration Rate Software, Transthoracic Impedance and End-Tidal Carbon Dioxide Waveforms. Each patient served as its own control.
Participants were monitored for average of 30 minutes
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 for 30 minutes
Study Arms (1)
In-patient Volunteers
In-patients from the hospital who choose to participate in the study
Eligibility Criteria
General Care Floor Patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (2)
The University of Colorado Health Sciences Center (UCHSC)
Denver, Colorado, 80262, United States
The Ohio State University Medical Center (OSUMC)
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ulf Borg, Director of Clinical Affairs
- Organization
- Covidien
Study Officials
- PRINCIPAL INVESTIGATOR
Sergio Bergese, MD
The Ohio State Medical Center, Dept of Anesthesia
- PRINCIPAL INVESTIGATOR
Robert McIntyre, MD
University of Colorado Denver, School of Medicine dept of Surgery Division of GI, Tumor and Endocrine Surgery
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
March 1, 2011
Study Start
February 1, 2011
Primary Completion
March 1, 2011
Study Completion
March 1, 2012
Last Updated
August 7, 2014
Results First Posted
January 10, 2013
Record last verified: 2014-08