COPDNCT04258982
The Copmparison of Accuracy of PtcCO2 and in PetCO2 in COPD Patients With NIV Treatment
An observational study of COPD, run by Zhenfeng He at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- COPD
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AECOPD patients with type II respiratory failure who need NIV treatment
Who may be able to join
- AECOPD patients with type II respiratory failure who need NIV treatment
Who cannot join
- hemodynamics is unstable;
- any other lung disease despite COPD;
- other diseases influencing experiments: Cognitive impairment disease mouth and nose trauma.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University.
Guangzhou, Guangdong
Zhenfeng He, MD, 8602083062882, zfHe_2019@163.com
About this study
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).
- Conditions
- COPD
- Being tested
- no intervention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| AECOPD group | The study incruit AECOPD patients with type II respiratory failure who need the NIV treatment. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
partial arterial pressure of end-tidal CO2 measured by prolong expiration method [PetCO2(P)]
PetCO2(P) will be measured before and after NIV treatment.
Measured: 2 hours
partial arterial pressure of transcutaneous CO2 (PtcCO2)
PtcCO2 will be measured before and after NIV treatment.
Measured: 2 hours
partial arterial pressure of carbon dioxide (PaCO2)
PaCO2 will be measured before and after NIV treatment.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start8 Feb 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhenfeng He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhenfeng He, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258982
- Sponsor's protocol ID
- GIRH-201927
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Copmparison of Accuracy of PtcCO2 and in PetCO2 in COPD Patients With NIV Treatment
- ClinicalTrials.gov ID
- NCT04258982
- Acronym / sponsor ID
- GIRH-201927
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Zhenfeng HeUniversity, hospital or other
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AECOPD group | – | Other: no interventionThe study incruit AECOPD patients with type II respiratory failure who need the NIV treatment. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AECOPD patients with type II respiratory failure who need NIV treatment
Key inclusion criteria (1 listed)
- AECOPD patients with type II respiratory failure who need NIV treatment
Key exclusion criteria (3 listed)
- hemodynamics is unstable;
- any other lung disease despite COPD;
- other diseases influencing experiments: Cognitive impairment disease mouth and nose trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | AECOPD group |
Primary outcome
partial arterial pressure of end-tidal CO2 measured by prolong expiration method [PetCO2(P)]
Time frame: 2 hours
PetCO2(P) will be measured before and after NIV treatment.
partial arterial pressure of transcutaneous CO2 (PtcCO2)
Time frame: 2 hours
PtcCO2 will be measured before and after NIV treatment.
partial arterial pressure of carbon dioxide (PaCO2)
Time frame: 2 hours
PaCO2 will be measured before and after NIV treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Zhenfeng He at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shanshan Zha, master (15013023031, zhass2011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
partial arterial pressure of end-tidal CO2 measured by prolong expiration method [PetCO2(P)] (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.