Novel Non-Invasive Monitoring Parameter in Healthy Volunteers

No Conditions Clinical Trial

Official title:

Novel Cardio-Respiratory Parameter in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294514
• Other study ID #: COVMOPR0132
• Status: Completed
• Phase: N/A
• First received: February 10, 2011
• Last updated: August 5, 2014
• Start date: February 2011
• Est. completion date: March 2012

Study information

• Verified date: August 2014
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Focus is Respiratory Rate
• No Conditions

Locations

Country	Name	City	State
United States	Covidien- RMS	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No