CO2-Patterns During Hyperoxia and Physical Exercise in COPD

COPD Clinical Trial

Official title:

CO2-Patterns During Hyperoxia and Physical Exercise in People With Severe COPD - a Randomized, Double-blind Cross Over Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04955561
• Other study ID #: CO2-Hyperoxia & Exercise
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2021
• Est. completion date: May 2022

Study information

• Verified date: July 2021
• Source: Schön Klinik Berchtesgadener Land
• Contact: Tessa Schneeberger
• Phone: +498652931540
• Email: TSchneeberger[@]Schoen-Klinik.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Hyperoxia

Intervention

Other:
• Oxygen 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.
• Medical Air
Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.
• 10L/min O2
Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.

Locations

Country	Name	City	State
Germany	Klinikum Berchtesgadener Land, Schön Kliniken	Schönau am Königssee

Sponsors (1)

Lead Sponsor	Collaborator
Schön Klinik Berchtesgadener Land

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PCO2 during hyperoxia at rest	pCO2 measured by capillary blood gases taken before and after the hyperoxia test	Change from baseline to after 10 minutes breathing 10L/min oxygen
Primary	Change in PCO2 from rest to end exercise (endurance shuttle walk test)	pCO2 measured by capillary blood gases taken before and after the ESWT	Change from baseline to the end of the ESWT, up to 20 minutes
Secondary	Transcutaneous partial pressure of CO2 (TcPCO2) during hyperoxia test	TcPCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)	Continuously from baseline to 10 minutes breathing 10L/min oxygen
Secondary	Transcutaneous partial pressure of CO2 (TcPCO2) during endurance shuttle walk test	TcPCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)	Continuously during ESWT, up to 20 minutes
Secondary	Breathing frequency during hyperoxia test	Breathing frequency during the hyperoxia test measured by ApneaLink Air™ (ResMed)	Continuously from baseline to 10 minutes breathing 10L/min oxygen
Secondary	Breathing frequency during endurance shuttle walk test	Breathing frequency during the ESWT measured by ApneaLink Air™ (ResMed)	Continuously during ESWT, up to 20 minutes
Secondary	Heart rate during endurance shuttle walk test	Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)	Continuously during ESWT, up to 20 minutes
Secondary	Heart rate during hyperoxia test	Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)	Continuously from baseline to 10 minutes breathing 10L/min oxygen
Secondary	Change of capillary partial pressure of O2 (pO2) during endurance shuttle walk test	pO2 measured by capillary blood gases taken before and after the ESWT	Change from baseline to the end of the ESWT, up to 20 minutes
Secondary	Change of inspiratory capacity during endurance shuttle walk test	IC measured by SpiroSense (Pari) before and after the ESWT	Change from baseline to the end of the ESWT, up to 20 minutes