CO2-Patterns During Hyperoxia and Physical Exercise in COPD

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

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

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Other: Oxygen therapy; Other: Medical Air; Other: 10L/min O2

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.

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tessa Schneeberger; Phone Number: +498652931540 +498652931540; Email: TSchneeberger@Schoen-Klinik.de

Study Locations

• Germany
  • Schönau am Königssee, Germany, 83471
    • Recruiting
    • Klinikum Berchtesgadener Land, Schön Kliniken
    • Contact: Tessa Schneeberger, MSc; Phone Number: 0049 - 8652 - 932730; Email: tschneeberger@schoen-klinik.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomised to begin with oxygen-supplementation at 10L/min during ESWT; 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	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.; Other: Medical Air; Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.; Other: 10L/min O2; Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.
Experimental: Randomised to begin with medical air supplementation at prescibed O2 flow rate during ESWT; 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	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.; Other: Medical Air; Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.; Other: 10L/min O2; Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.
Experimental: Randomised to begin with oxygen supplementation at prescibed O2 flow rate during ESWT; 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	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.; Other: Medical Air; Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.; Other: 10L/min O2; Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Breathing frequency during endurance shuttle walk test	Breathing frequency during the ESWT measured by ApneaLink Air™ (ResMed)	Continuously during ESWT, up to 20 minutes
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
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
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
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

Collaborators and Investigators

• Sponsor: Schön Klinik Berchtesgadener Land

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: oxygen; walking exercise; CO2
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hyperoxia
• Other Study ID Numbers: CO2-Hyperoxia & Exercise

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

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