COPD
Conditions
Keywords
CO2, oxygen, walking exercise
Brief summary
The aim of the study is to investigate a possible correlation between the change in PCO2 during a hyperoxia-test and the change in PCO2 during walking in people with COPD
Detailed description
Rationale: Carbon dioxide partial pressure (PCO2) varies significantly in patients with advanced chronic obstructive pulmonary disease (COPD). Data from the Swedish LTOT Registry showed that PCO2 is an independent predictor for mortality and that there is a U-shaped relationship. Patients with advanced COPD who are still normocapnic at rest may still develop a clinically relevant, exercise-induced carbon dioxide (CO2) retention during exercise/ activity. It is also known that altered breathing patterns at night in COPD patients can lead to nocturnal hypercapnia, especially during REM sleep. The course of PCO2 cannot be reliably predicted by lung function parameters or resting blood gas analysis. Since exercise tests with blood gas control or nightly PCO2 monitoring are rarely performed in clinical routine, exercise induced CO2 retention often remains undetected. In the literature, there is little information on PCO2 behaviour under everyday conditions (with or without LTOT) such as rest, physical exertion and nightly sleep. Therefore, predictors that could describe the PCO2 patterns are missing. However, one former study by O'Donnel from 2002 showed that the change in CO2 under hyperoxia conditions could provide predictive information for the change in CO2 with exercise. Objective: Primary aim of this study is to investigate whether the change of PCO2 during a hyperoxia-test (10l/min O2 at rest) correlates with the change of PCO2 during walking exercise with either a: l/min O2 as prescribed; b: medical air; c: 10l/min O2. Design: This study is a randomized, controlled cross-over trial. Following an initial maximal incremental shuttle walk test (ISWT), the participant will perform 3 endurance shuttle walk tests (ESWT) at 85% of the maximum ISWT pace on three consecutive days (24h break between ESWTs). In a randomized order, participants will perform one ESWTs with O2-flow as prescribed (e.g. study day 1), one with medical air (same flow rate as prescribed oxygen) (e.g. study day 2) and one with 10l/min O2 (e.g. study day 3). An additional hyperoxia test (10l/min O2 for ten minutes; at resting condition) will be perfomed on each day prior to performing an ESWT.
Interventions
OTHEROxygen therapy
Supplemental O2 at rest of 10 l/min for ten minutes followed by supplemental O2 at the prescribed exercise O2-flow rate during ESWT.
OTHERMedical Air
Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.
OTHER10L/min O2
Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.
Sponsors
Schön Klinik Berchtesgadener Land
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* COPD III/ IV * 35mmHg \< PCO2 \<= 55mmHg (under resting conditions, breathing room air) * Hypoxemia (PaO2\<60mmHg) under room air conditions (rest or during exercise) or SpO2 \<88% during exercise * established oxygen therapy or given indication for oxygen therapy * written informed consent
Exclusion criteria
* acute exacerbation of COPD * exercise limiting cardiac or orthopedic comorbidites * PaO2 \<50mmHg at rest, breathing room air
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PCO2 during hyperoxia at rest | Change from baseline to after 10 minutes breathing 10L/min oxygen | pCO2 measured by capillary blood gases taken before and after the hyperoxia test |
| Change in PCO2 from rest to end exercise (endurance shuttle walk test) | Change from baseline to the end of the ESWT, up to 20 minutes | pCO2 measured by capillary blood gases taken before and after the ESWT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of inspiratory capacity during endurance shuttle walk test | Change from baseline to the end of the ESWT, up to 20 minutes | IC measured by SpiroSense (Pari) before and after the ESWT |
| Transcutaneous partial pressure of CO2 (TcPCO2) during hyperoxia test | Continuously from baseline to 10 minutes breathing 10L/min oxygen | TcPCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland) |
| Transcutaneous partial pressure of CO2 (TcPCO2) during endurance shuttle walk test | Continuously during ESWT, up to 20 minutes | TcPCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland) |
| Heart rate during hyperoxia test | Continuously from baseline to 10 minutes breathing 10L/min oxygen | Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland) |
| Breathing frequency during endurance shuttle walk test | Continuously during ESWT, up to 20 minutes | Breathing frequency during the ESWT measured by ApneaLink Air™ (ResMed) |
| Heart rate during endurance shuttle walk test | Continuously during ESWT, up to 20 minutes | Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland) |
| Breathing frequency during hyperoxia test | Continuously from baseline to 10 minutes breathing 10L/min oxygen | Breathing frequency during the hyperoxia test measured by ApneaLink Air™ (ResMed) |
| Change of capillary partial pressure of O2 (pO2) during endurance shuttle walk test | Change from baseline to the end of the ESWT, up to 20 minutes | pO2 measured by capillary blood gases taken before and after the ESWT |
Countries
Germany
Contacts
Primary ContactTessa Schneeberger
Outcome results
None listed