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Completed

NCT Number: NCT03554629

A Comparison of Capnography Sampling Lines

This study evaluates the performance of eight (8) cleared capnography carbon dioxide (CO2) sampling filterlines during patient simulated scripted activities when connected to a Medtronic (MDT) dual parameter monitor.

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Key information

Conditions

Capnography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinimark LLC

Louisville, Colorado, 80027, United States

About this study

The eight (8) Capnography CO2 Sampling Filterlines (CCSF) have different designs for obtaining a gas sample for CO2 measurement and also for delivering supplemental oxygen (O2).

In this study awake, healthy volunteers will evaluate the 8 CCSF (Capnography CO2 Sampling Filterline) to determine their performance variability in providing a representative exhaled CO2 sample for measurement on the Capnostream 35 dual parameter monitor during scripted activities of closed mouth/open mouth breathing during both high and low respiration rate with supplemental oxygen delivery at 5lpm.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Non-hospitalized adults ≥ 18 years old.
  • Willing and able to give informed consent.

Exclusion criteria

  • Lack of an informed consent.
  • Subjects not able to accommodate the proper application of the cannula.
  • Subject not willing or able to comply fully with the study procedures.
  • Subjects with sensitivity to nasal cannula in both nares.
  • Subject with skin allergies to medical adhesives.
  • Subjects with runny nose the day of the study participation.
  • Subject, who in the opinion of the Principal Investigator, should not be enrolled.

Treatment and study plan

Capnography CO2 cannula sampling Flexiterline (CCSF) designs with supplemental O2

Device

Use of 8 post-market nasal CO2 cannula sampling filterlines; 4 nasal only sampling ports manufactured by Medtronic, Salter, Hudson/Teleflex and FlexiCare) and 4 post-market oral/nasal sampling ports manufactured by Medtronic, Salter, Dispo-Med and Westmed during scripted activity with supplemental O2.

Primary outcomes

  1. Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity

    Time frame: Three hours

    Comparison of measured end-tidal CO2 (EtCO2), Rebreathing as measured by fractional inspiratory CO2 (FiCO2) as a function the activity for 8 different CCSF designs tested on 23 subjects with supplemental O2 at 5lmp for four activities.

    Device data collected a 20Hz (20 data points/second) for the 3 hours of enrollment.

    Participants lateral lying with head on a pillow with supplemental O2 during each nasal only or open mouth breathing at respiration rate of 6 and 24.

Secondary outcomes

  1. Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 24

    Time frame: Three hours

    Gas sample provided by CCSF to the Capnostream 35 for measurement of the partial pressure of CO2 as a function of time.

    The Capnostream 35 Respiration rate algorithm counts the breaths per minute based upon the frequency of a CO2 validated breath waveform.

  2. Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 6

    Time frame: Three hours

    Gas sample provided by CCSF to the Capnostream 35 for measurement of the partial pressure of CO2 as a function of time.

    The Capnostream 35 Respiration rate algorithm counts the breaths per minute based upon the frequency of a CO2 validated breath waveform.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Acronym: FRS

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 13, 2018
Registry last updated
Jan 6, 2021

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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