CO2-Patterns During Hyperoxia and Physical Exercise in COPD

NCT04955561 | Unknown

• 1 other identifier: CO2-Hyperoxia & Exercise
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Conditions

COPD

Keywords

CO2; oxygen; walking exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Transcutaneous partial pressure of CO2 (TcPCO2) during hyperoxia test

  Continuously from baseline to 10 minutes breathing 10L/min oxygen

• Transcutaneous partial pressure of CO2 (TcPCO2) during endurance shuttle walk test

  Continuously during ESWT, up to 20 minutes

• Breathing frequency during hyperoxia test

  Continuously from baseline to 10 minutes breathing 10L/min oxygen

• Breathing frequency during endurance shuttle walk test

  Continuously during ESWT, up to 20 minutes

• Heart rate during endurance shuttle walk test

  Continuously during ESWT, up to 20 minutes

Study Arms (3)

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

EXPERIMENTAL

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; Other: Medical Air; Other: 10L/min O2

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

EXPERIMENTAL

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; Other: Medical Air; Other: 10L/min O2

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

EXPERIMENTAL

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; Other: Medical Air; Other: 10L/min O2

Interventions

Oxygen therapy OTHER

Supplemental O2 at rest of 10 l/min for ten minutes followed by supplemental O2 at the prescribed exercise O2-flow rate during ESWT.

Randomised to begin with medical air supplementation at prescibed O2 flow rate during ESWT; Randomised to begin with oxygen supplementation at prescibed O2 flow rate during ESWT; Randomised to begin with oxygen-supplementation at 10L/min during ESWT

Medical Air OTHER

Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.

Randomised to begin with medical air supplementation at prescibed O2 flow rate during ESWT; Randomised to begin with oxygen supplementation at prescibed O2 flow rate during ESWT; Randomised to begin with oxygen-supplementation at 10L/min during ESWT

10L/min O2 OTHER

Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.

Randomised to begin with medical air supplementation at prescibed O2 flow rate during ESWT; Randomised to begin with oxygen supplementation at prescibed O2 flow rate during ESWT; Randomised to begin with oxygen-supplementation at 10L/min during ESWT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD III/ IV
• mmHg \< 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

You may not qualify if:

• acute exacerbation of COPD
• exercise limiting cardiac or orthopedic comorbidites
• PaO2 \<50mmHg at rest, breathing room air

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead

Study Sites (1)

Klinikum Berchtesgadener Land, Schön Kliniken

Schönau am Königssee, 83471, Germany

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Oxygen; Air

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Central Study Contacts

Tessa Schneeberger

CONTACT

+498652931540; TSchneeberger@Schoen-Klinik.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: July 9, 2021
• Study Start: July 13, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

DE (1)