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Assessment of End-tidal Carbon Dioxide Levels in Respiratory Disease

Sponsor
National Hospital Organization Minami Kyoto Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05188976
Collaborator
(none)
40
Enrollment
1
Location
24
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Validity Assessment of End-tidal Carbon Dioxide Levels in Respiratory Disease
    Actual Study Start Date :
    Dec 1, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between PetCO2, PaCO2, and PtcCO2 [One to three months]

    Secondary Outcome Measures

    1. Correlation of changes over time between PetCO2, PaCO2 , and PtcCO2 [One to three months]

    2. Relationship between PetCO2 and respiratory symptoms evaluated by The COPD Assessment Test (CAT) and mMRC (modified British Medical Research Council) [One to three months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Hospital Organization Minami Kyoto Hospital Joyo Kyoto Japan 610-0113

    Sponsors and Collaborators

    • National Hospital Organization Minami Kyoto Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Hospital Organization Minami Kyoto Hospital
    ClinicalTrials.gov Identifier:
    NCT05188976
    Other Study ID Numbers:
    • 2020-31
    First Posted:
    Jan 12, 2022
    Last Update Posted:
    Jan 27, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Hospital Organization Minami Kyoto Hospital
    PetCO2
    Additional relevant MeSH terms:
    Respiration Disorders
    Respiratory Tract Diseases

    Study Results

    No Results Posted as of Jan 27, 2022