A Comparison of Capnography Sampling Lines

NCT03554629 | Completed Results FDA Device

• 1 other identifier: MDT17063FRS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Capnography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (1)

Capnography CO2 Sampling Filterline Performance

OTHER

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.

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

Interventions

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

Capnography CO2 Sampling Filterline Performance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-hospitalized adults ≥ 18 years old.
• Willing and able to give informed consent.

You may not qualify if:

• Lack of an informed consent.
• Subjects not able to accommodate the proper application of the cannula.
• Subject not willing or able to comply fully with the study procedures.
• Subjects with sensitivity to nasal cannula in both nares.
• Subject with skin allergies to medical adhesives.
• Subjects with runny nose the day of the study participation.
• Subject, who in the opinion of the Principal Investigator, should not be enrolled.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Clinimark LLC

Louisville, Colorado, 80027, United States

Location

Limitations and Caveats

Strategy to test four simulated patient activities that would most likely effect a quality gas sample for measurement of CO2 partial pressure was selected to maintain active enrollment to three hours .

Results Point of Contact

• Title: Kathleen H. Niebel RN BSN BSME
• Organization: Clinical Research Program Manager

kathleen.h.niebel@gmail.com

978-549-9325

Study Officials

• Thomas A Miner, MD

  Clinimark, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: June 13, 2018
• Study Start: May 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: September 15, 2020
• Last Updated: January 6, 2021
• Results First Posted: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)