Assessment of End-tidal Carbon Dioxide Levels in Respiratory Disease

Respiratory Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05188976
• Other study ID #: 2020-31
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: National Hospital Organization Minami Kyoto Hospital
• Contact: Yuichi Chihara, MD., PhD.
• Phone: 81-774-52-0065
• Email: yc.r03107[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Locations

Country	Name	City	State
Japan	National Hospital Organization Minami Kyoto Hospital	Joyo	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
National Hospital Organization Minami Kyoto Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between PetCO2, PaCO2, and PtcCO2		One to three months
Secondary	Correlation of changes over time between PetCO2, PaCO2 , and PtcCO2		One to three months
Secondary	Relationship between PetCO2 and respiratory symptoms evaluated by The COPD Assessment Test (CAT) and mMRC (modified British Medical Research Council)		One to three months