Assessment of End-tidal Carbon Dioxide Levels in Respiratory Disease

March 25, 2023 updated by: National Hospital Organization Minami Kyoto Hospital

Validity Assessment of End-tidal Carbon Dioxide Levels in Respiratory Disease

The investigators aim to evaluate the correlation between PetCO2, PaCO2, and PtcCO2 in patients with respiratory diseases. The investigators also evaluate the correlation between PetCO2, PaCO2, and PtcCO2 changes over time.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Partial pressure of carbon dioxide(PCO2) is mainly evaluated by partial pressure of arterial carbon dioxide (PaCO2), and is used as an index for prognosis and NPPV introduction in chronic respiratory failure. Arterial blood gas analysis for PaCO2 measurement is the most accurate test value, but it is invasive and frequent tests are difficult and cannot be performed at home. The transcutaneous PCO2 (PtcCO2) is a non-invasive measurement and its measured value is close to PaCO2, and it can be measured continuously, which is useful for monitoring patients with chronic respiratory failure. However, PtcCo2 has not been applied at home due to technical problems (necessity of calibration, periodic drift, etc.). The end-tidal pressure of expired CO2 (PetCO2) can be measured non-invasively, easily and continuously. PetCO2 is mainly used for patients undergoing mechanical ventilation, and its accuracy and stability have been evaluated. The investigators decided to investigate whether PetCO2 is useful for monitoring respiratory status in patients with respiratory disorder.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kyoto
      • Joyo, Kyoto, Japan, 610-0113
        • Recruiting
        • National Hospital Organization Minami Kyoto Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with respiratory disease such as COPD, IP

Description

Inclusion Criteria:

  • Subjects with respiratory disorder.
  • Subjects who are clinically stable for the last 2 weeks

Exclusion Criteria:

  • Subjects who required treatment with antibacterial agents or oral/intravenous steroids for pneumonia or exacerbation of respiratory disease in the last 2 weeks.
  • Subjects with severe complications such as cardiovascular disease, liver disease, renal disease, and neurological disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between PetCO2, PaCO2, and PtcCO2
Time Frame: One to three months
One to three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of changes over time between PetCO2, PaCO2 , and PtcCO2
Time Frame: One to three months
One to three months
Relationship between PetCO2 and respiratory symptoms evaluated by The COPD Assessment Test (CAT) and mMRC (modified British Medical Research Council)
Time Frame: One to three months
One to three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Hospital Organization Minami Kyoto Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

December 27, 2021

First Submitted That Met QC Criteria

December 27, 2021

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 25, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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