The Copmparison of Accuracy of PtcCO2 and in PetCO2 in COPD Patients With NIV Treatment

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 Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Shanshan Zha, master; Phone Number: 15013023031; Email: zhass2011@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

AECOPD patients with type II respiratory failure who need NIV treatment

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AECOPD group; The study incruit AECOPD patients with type II respiratory failure who need the NIV treatment.	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zhenfeng He

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: February 2, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 21, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: GIRH-201927

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No