Novel Non-Invasive Monitoring Parameter in Healthy Volunteers

Novel Cardio-Respiratory Parameter in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: No Conditions; Focus is Respiratory Rate

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80301
      • Covidien- RMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy Volunteers; Healthy volunteers ASA Class 1

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.	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.	Participants were monitorerd on average of 30 minute period

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.	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 of 30 minute periods

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Scott Kelley, MD, Medtronic - MITG

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: February 10, 2011
• First Posted (Estimate): February 11, 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: Respiratory Rate
• Other Study ID Numbers: COVMOPR0132