Novel Non-Invasive Monitoring Parameter in a Hospital Setting

Completed

• Conditions: Respiratory Failure; Respiratory Insufficiency

• Registration Number: NCT01306201
• Lead Sponsor: Medtronic - MITG

Brief Summary

Data collected from this study will be used to evaluate the performance of a monitoring algorithm.

Detailed Description

The goal of this study is to assess equivalency, performance, and accuracy of a new monitoring algorithm in a hospital setting.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-28
• Primary Completion: 2011-03
• Study First Posted: 2011-03-01
• Study Completion: 2012-03
• Results First Submitted: 2012-05-02
• Results First Submitted QC: 2012-12-07
• Results First Posted: 2013-01-10
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

1. Subjects 18 years old or older
2. Written informed consent from the patient or their legally authorized representative before initiation of any study-related procedures
3. Subjects on general care floor

Exclusion Criteria

1. Severe contact allergies to standard adhesive materials
2. Abnormalities that may prevent proper application of the device
3. Women who are pregnant or lactating
4. Subjects with significant arrhythmia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Participants were monitored for average of 30 minutes	Mean and standard deviations of respiration rates collected from patients in the hospital settings were compared between Covidien Respiration Rate Software, Transthoracic Impedance and End-Tidal Carbon Dioxide Waveforms. Each patient served as its own control.

Secondary Outcome Measures

Name	Time	Method
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.	Participants were monitored on average for 30 minutes	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

Trial Locations

Locations (2)

The University of Colorado Health Sciences Center (UCHSC); 🇺🇸 Denver, Colorado, United States

The Ohio State University Medical Center (OSUMC); 🇺🇸 Columbus, Ohio, United States