Novel Non-Invasive Monitoring Parameter… | Clinical Trial

Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Failure Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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 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 outcomes

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 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

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

A Novel Cardio-Respiratory Parameter in a Hospital Setting

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2012
First posted: Mar 1, 2011
Registry last updated: Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed