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OpenTrials
Completed

NCT Number: NCT01294514

Novel Non-Invasive Monitoring Parameter in Healthy Volunteers

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

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Key information

Conditions

no Conditions Focus is Respiratory Rate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Covidien- RMS

Boulder, Colorado, 80301, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    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

Novel Cardio-Respiratory Parameter in Healthy Volunteers

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Feb 11, 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.

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