A Comparison of Capnography Sampling Lines

NCT ID: NCT03554629

Last Updated: 2021-01-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2020-09-15

Brief Summary

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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

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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

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Capnography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Capnography CO2 Sampling Filterline Performance

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.

Group Type OTHER

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

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas A Miner, MD

Role: PRINCIPAL_INVESTIGATOR

Clinimark, LLC

Locations

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Clinimark LLC

Louisville, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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MDT17063FRS

Identifier Type: -

Identifier Source: org_study_id

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