NCT04051931

Brief Summary

The pathophysiological characteristics of COPD is irreversible airflow restriction which may influence the gas exchange and cause the abnormal PaO2 and PaCO2. Assessment of the partial arterial pressure of carbon dioxide (PaCO2 ) is the 'gold standard' for the evaluation of the adequacy of alveolar ventilation.Method used mostly nowadays : arterial puncture which is accurate but is invasive 、painful、 non-dynamic and there is risk of infection and tissue、nerve damage. Noninvasive measurement methods (Most commonly used): end-tidal CO2( ETCO2)、 transcutaneous CO2(TcCO2). They all can monitor the PaCO2 dynamically、 noninvasively, but is existence of controversy of the accuracy. So the investigators want to compare the accuracy of these two noninvasive methods for assessment of PaCO2.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

August 10, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

10 months

First QC Date

July 29, 2019

Last Update Submit

October 21, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • concordance between the values of PetCO2 and PaCO2 measured at the same time

    concordance between the values of PetCO2 and PaCO2 measured at the same time

    1 hour

  • concordance between the values of PtcO2 and PaCO2 measured at the same time

    concordance between the values of PtcO2 and PaCO2 measured at the same time

    1 hour

Study Arms (2)

stable COPD group

include COPD patients with stable state

AECOPD group

include COPD patients with acute exacerbation

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

stable and acute axcerbation COPD patients

You may qualify if:

  • COPD patients

You may not qualify if:

  • hemodynamics is unstable;
  • any other lung disease despite COPD;
  • other diseases influencing experiments: Cognitive impairment disease、 mouth and nose trauma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

  • Zha S, He Z, Niu J, Huang Q, Liang Z, Zhou Z, Yang H, Lin S, Guan L, Zhou L, Chen R. Comparison of prolonged exhalation end-tidal CO(2) and transcutaneous CO(2) monitoring in COPD patients. Crit Care. 2026 Jan 20. doi: 10.1186/s13054-025-05834-5. Online ahead of print.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Shanshan Zha, master

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

July 29, 2019

First Posted

August 9, 2019

Study Start

August 10, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

October 23, 2019

Record last verified: 2019-10

Locations