Evaluation of capnographic differences in COPD patients with and without hypercapnia

Recruiting

Conditions: J44
Other chronic obstructive pulmonary disease

Registration Number: DRKS00034154

Lead Sponsor: umetry Diagnostics GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Ability to consent
2. Written informed consent
3. Patients with severe stage COPD (GOLD stage 3 and 4)
4. Patients without hypocapnia (patients with paCO2>35mmHg)
5. Patients must be able to sit upright for several minutes without fatigue
6. Patients must be able to go 10 minutes without supplemental oxygen (as assessed by the investigator).

Exclusion Criteria

1. Patients who, in the opinion of the investigator, are unsuitable for participation in this study or cannot fulfil the requirements of the study.
2. Currently participating in a clinical trial that could influence respiratory behaviour (drug, medical device) or within the last 30 days prior to the study. This is at the discretion of the investigator.
3. Participation in this study at an earlier date.
4. Patients with previously documented heart failure with an ejection fraction below 45% or acute hydropic decompensation.
5. Patients with documented neuromuscular and diaphragmatic restrictions.
6. Patients with mouth closure problems.
7. Patients with a respiratory rate > 22 breaths per minute at rest.
8. Acute pulmonary exacerbation with inflammatory activity or acute pulmonary infection within 4 weeks prior to screening.
9. Patients who are potentially or manifestly pregnant.
10. Hypersensitivity to the ingredients of the hyperaemising ointment (Finalgon).

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Evaluation of the differences in pCO2 from capillary BGA and petCO2 from different breathing manoeuvres in COPD patients with and without hypercapnia.<br><br>2. Evaluation of the changes in petCO2 during different breathing manoeuvres in COPD patients with and without hypercapnia.

Secondary Outcome Measures

Name	Time	Method
1. Evaluation of the applicability/feasibility of the lumetry research device.<br><br>2. Comparison of pCO2 and petCO2 with transcutaneous CO2 (tCO2) measurements at rest.