A Comparison of Capnography Sampling Lines

Not Applicable

Completed

• Conditions: Capnography

• Registration Number: NCT03554629
• Lead Sponsor: Medtronic - MITG

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-05-01
• Study First Submitted QC: 2018-05-31
• Study First Posted: 2018-06-13
• Primary Completion: 2019-08-31
• Results First Submitted: 2020-08-28
• Study Completion: 2020-09-15
• Results First Submitted QC: 2020-11-19
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-14
• Results First Posted: 2020-12-16
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity	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 Outcome Measures

Name	Time	Method
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	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.
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	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.

Trial Locations

Locations (1)

Clinimark LLC; 🇺🇸 Louisville, Colorado, United States