NCT03554629

A Comparison of Capnography Sampling Lines

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Capnography

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-08-31
• Completion: 2020-09-15
• First posted: 2018-06-13
• Last updated: 2021-01-06
• Results posted: 2020-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study