A Comparison of Capnography Sampling Lines

Capnography Clinical Trial

— FRS  

Official title:

A Comparison of Capnography Sampling Lines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554629
• Other study ID #: MDT17063FRS
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: September 15, 2020

Study information

• Verified date: December 2020
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 15, 2020
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Non-hospitalized adults = 18 years old.

2. Willing and able to give informed consent.

Exclusion Criteria:

1. Lack of an informed consent.

2. Subjects not able to accommodate the proper application of the cannula.

3. Subject not willing or able to comply fully with the study procedures.

4. Subjects with sensitivity to nasal cannula in both nares.

5. Subject with skin allergies to medical adhesives.

6. Subjects with runny nose the day of the study participation.

7. Subject, who in the opinion of the Principal Investigator, should not be enrolled.

Related Conditions & MeSH terms

• Capnography

Intervention

Device:
• Capnography CO2 cannula sampling Flexiterline (CCSF) designs with supplemental O2
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.

Locations

Country	Name	City	State
United States	Clinimark LLC	Louisville	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	Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity	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.	Three hours
Secondary	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	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.	Three hours
Secondary	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	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.	Three hours