A Comparison of Capnography Sampling Lines (FRS)

Medtronic

Status: Completed

Conditions: Capnography

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03554629

MDT17063FRS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Capnography CO2 Sampling Filterline Performance

Other group

Description:

Adult volunteer exhaled gas was sampled by 8 different CO2 cannula sampling filterline (CCSF) designs connected to a Capnostream 35 for measurement of CO2 during patient simulated scripted activities in order to assess patient interface design performance to provide a quality gas sample for CO2 partial pressure measurement.

Treatment:

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