NCT04258982

Brief Summary

The chronic obstructive pulmonary disease (COPD) patients with type II respiratory failure always needs PaCO2 test to monitor the changes of disease. Method used mostly nowadays to detect PaCO2 is arterial puncture which is accurate but is invasive, painful and non-dynamic. Noninvasive measurement methods includes end-tidal CO2 (PetCO2), transcutaneous CO2 (PtcCO2) which can monitor the PaCO2 dynamically and noninvasively, but their accuracy is in controversy. Common PetCO2 is especially inaccurate in COPD patients while our team find that the accuracy can be improved by prolong expiration method (PetCO2 (P)).So the investigators want to compare the accuracy of PtcCO2 and PetCO2(P) in AECOPD patients during noninvasive ventilation(NIV).

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
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

2.9 years

First QC Date

February 2, 2020

Last Update Submit

February 21, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • partial arterial pressure of end-tidal CO2 measured by prolong expiration method [PetCO2(P)]

    PetCO2(P) will be measured before and after NIV treatment.

    2 hours

  • partial arterial pressure of transcutaneous CO2 (PtcCO2)

    PtcCO2 will be measured before and after NIV treatment.

    2 hours

  • partial arterial pressure of carbon dioxide (PaCO2)

    PaCO2 will be measured before and after NIV treatment.

    2 hours

Study Arms (1)

AECOPD group

The study incruit AECOPD patients with type II respiratory failure who need the NIV treatment.

Other: no intervention

Interventions

no intervention

AECOPD group

Eligibility Criteria

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

AECOPD patients with type II respiratory failure who need NIV treatment

You may qualify if:

  • AECOPD patients with type II respiratory failure who need NIV treatment

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, China

RECRUITING

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
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 2, 2020

First Posted

February 6, 2020

Study Start

February 8, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations