CO2-Patterns During Hyperoxia and Physical Exercise in COPD

Schön Klinik Berchtesgadener Land

Status: Unknown

Conditions: COPD

Treatments: Other: Medical Air; Other: 10L/min O2; Other: Oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04955561

CO2-Hyperoxia & Exercise

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

55 participants in 3 patient groups

Randomised to begin with oxygen-supplementation at 10L/min during ESWT

Experimental group

Description:

Randomised order of tests starting with the 10L/min O2, during the ESWT followed by prescribed O2 flow rate or medical air in randomised order on seperate days

Treatment:

Other: 10L/min O2

Other: Medical Air

Other: Oxygen therapy

Randomised to begin with medical air supplementation at prescibed O2 flow rate during ESWT

Experimental group

Description:

Randomised order of tests starting with the medical air during the ESWT followed by prescribed O2 flow rate or 10L/min O2 in randomised order on seperate days

Treatment:

Other: 10L/min O2

Other: Medical Air

Other: Oxygen therapy

Randomised to begin with oxygen supplementation at prescibed O2 flow rate during ESWT

Experimental group

Description:

Randomised order of tests starting with the prescribed O2 flow rate, during the ESWT followed by 10L/min O2 or medical air in randomised order on seperate days

Treatment:

Other: 10L/min O2

Other: Medical Air

Other: Oxygen therapy