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: August 5, 2014
Last verified: August 2014
  Purpose

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


Condition
No Conditions
Focus is 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
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, see Learn About Clinical Studies.

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: August 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Covidien:
Respiratory Rate

ClinicalTrials.gov processed this record on October 23, 2014