Novel Non-Invasive Monitoring Parameter in a Hospital Setting

August 5, 2014 updated by: Medtronic - MITG

A Novel Cardio-Respiratory Parameter in a Hospital Setting

Data collected from this study will be used to evaluate the performance of a monitoring algorithm.

Study Overview

Status

Completed

Conditions

Detailed Description

The goal of this study is to assess equivalency, performance, and accuracy of a new monitoring algorithm in a hospital setting.

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

General Care Floor Patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
In-patient Volunteers
In-patients from the hospital who choose to participate in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 monitored for average of 30 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Participants were monitored on average for 30 minutes

The data used for analysis consisted of multiple simultaneous measures of RR_TTI, RR_V1.0 and RR_EtCO2 for each subject. Given N sets of simultaneous RR values for each of P patients, the simultaneous RR values were used to calculate a pair of RMSD values for each subject.

The two RMSD values, RMSDRR_V1.0_vs_EtCO2, and RMSDTTI_vs_EtCO2, quantify the mean absolute difference in simultaneous estimates of respiratory rate between RR_V1.0 compared with RR_EtCO2 and RR_TTI compared with RR_EtCO2, respectively for the subjects with 95% confidence of mean ± 3.38 BrPM. The Measure type is Number and represents the RMSD of Covidien Nellcor Respiration Rate Software
Participants were monitored on average for 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 10, 2011

First Submitted That Met QC Criteria

February 28, 2011

First Posted (Estimate)

March 1, 2011

Study Record Updates

Last Update Posted (Estimate)

August 7, 2014

Last Update Submitted That Met QC Criteria

August 5, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVMOPR0131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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