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Novel Non-Invasive Monitoring Parameter in a Hospital Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01306201
Recruitment Status : Completed
First Posted : March 1, 2011
Results First Posted : January 10, 2013
Last Update Posted : August 7, 2014
Information provided by (Responsible Party):
Medtronic - MITG

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

Condition or disease
Respiratory Insufficiency Respiratory Failure

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

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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Novel Cardio-Respiratory Parameter in a Hospital Setting
Study Start Date : February 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  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. [ 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.

Secondary Outcome Measures :
  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. [ 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
General Care Floor Patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01306201

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United States, Colorado
The University of Colorado Health Sciences Center (UCHSC)
Denver, Colorado, United States, 80262
United States, Ohio
The Ohio State University Medical Center (OSUMC)
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Medtronic - MITG
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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
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Responsible Party: Medtronic - MITG Identifier: NCT01306201    
Other Study ID Numbers: COVMOPR0131
First Posted: March 1, 2011    Key Record Dates
Results First Posted: January 10, 2013
Last Update Posted: August 7, 2014
Last Verified: August 2014
Keywords provided by Medtronic - MITG:
Hospital Setting
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases