Novel Non-Invasive Monitoring Parameter in Healthy Volunteers

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: NCT01294514
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : January 10, 2013
Last Update Posted : August 7, 2014
Information provided by (Responsible Party):
Medtronic - MITG

Brief Summary:
The purpose of this study is to study Non-Invasive Performance evaluation of monitoring algorithm.

Condition or disease
No Conditions Focus is Respiratory Rate

Detailed Description:
Assess equivalency, performance, and accuracy of a new monitoring algorithm in Healthy Volunteers.

Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Novel Cardio-Respiratory Parameter in Healthy Volunteers
Study Start Date : February 2011
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2012

Healthy Volunteers
Healthy volunteers ASA Class 1

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 monitorerd on average of 30 minute period ]
    Mean and standard deviations of respiration rates collected from healthy volunteers were compared between Covidien Respiration Rate Software, Transthoracic Impedance and Overscored End-Tidal Carbon Dioxide Waveforms. Each volunteer 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 of 30 minute periods ]

    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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Volunteers

Inclusion Criteria:

  • Subject is 18 or older
  • Subject is willing and able to provide written consent

Exclusion Criteria:

  • Severe contact allergies to standard adhesive materials
  • Subjects with abnormalities that may prevent proper application of the device
  • Women who are pregnant or lactating
  • Subjects with significant Arrhythmias

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): NCT01294514

United States, Colorado
Covidien- RMS
Boulder, Colorado, United States, 80301
Sponsors and Collaborators
Medtronic - MITG
Principal Investigator: Scott Kelley, MD Medtronic - MITG

Responsible Party: Medtronic - MITG Identifier: NCT01294514     History of Changes
Other Study ID Numbers: COVMOPR0132
First Posted: February 11, 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:
Respiratory Rate