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A Novel Cardio-Respiratory Parameter in a Hospital Setting

18 Years
Not Enrolling
Respiratory Conditions

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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:


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:


Principal Investigator

Sergio Bergese, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Ohio State Medical Center, Dept of Anesthesia


United States: Institutional Review Board

Study ID:




Start Date:

February 2011

Completion Date:

March 2012

Related Keywords:

  • Respiratory Conditions
  • Hospital Setting



The University of Colorado Health Sciences Center (UCHSC) Denver, Colorado  80262
The Ohio State University Medical Center (OSUMC) Columbus, Ohio  43210