A Novel Cardio-Respiratory Parameter in a Hospital Setting
18 Years
N/A
Both
Respiratory Conditions
Trial Information
A Novel Cardio-Respiratory Parameter in a Hospital Setting
The goal of this study is to assess equivalency, performance, and accuracy of a new
monitoring algorithm in a hospital setting.
Inclusion Criteria:
1. Subjects 18 years old or older
2. Written informed consent from the patient or their legally authorized representative
before initiation of any study-related procedures
3. Subjects on general care floor
Exclusion Criteria:
1. Severe contact allergies to standard adhesive materials
2. Abnormalities that may prevent proper application of the device
3. Women who are pregnant or lactating
4. Subjects with significant arrhythmia
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
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.
Outcome Description:
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.
Outcome Time Frame:
Participants were monitored for average of 30 minutes
Safety Issue:
No
Principal Investigator
Sergio Bergese, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Ohio State Medical Center, Dept of Anesthesia
Authority:
United States: Institutional Review Board
Study ID:
COVMOPR0131
NCT ID:
NCT01306201
Start Date:
February 2011
Completion Date:
March 2012
Related Keywords:
- Respiratory Conditions
- Hospital Setting
Name | Location |
|---|---|
| The University of Colorado Health Sciences Center (UCHSC) | Denver, Colorado 80262 |
| The Ohio State University Medical Center (OSUMC) | Columbus, Ohio 43210 |
