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Novel Non-Invasive Monitoring Parameter in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01294514
First received: February 10, 2011
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition
Focus of the Study is Measuring Respiratory Rate

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Novel Cardio-Respiratory Parameter in Healthy Volunteers

Further study details as provided by Covidien:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]

    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



Enrollment: 27
Study Start Date: February 2011
Study Completion Date: March 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy Volunteers
Healthy volunteers ASA Class 1

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy Volunteers

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294514

Locations
United States, Colorado
Covidien- RMS
Boulder, Colorado, United States, 80301
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Scott Kelley, MD Covidien
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01294514     History of Changes
Other Study ID Numbers: COVMOPR0132
Study First Received: February 10, 2011
Results First Received: May 2, 2012
Last Updated: April 18, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013