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CO2-Patterns During Hyperoxia and Physical Exercise in COPD

13. juli 2021 opdateret af: Klaus Kenn, Schön Klinik Berchtesgadener Land

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

55

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyskland
      • Schönau am Königssee, Tyskland, 83471
        • Rekruttering
        • Klinikum Berchtesgadener Land, Schön Kliniken
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Andet: 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.
Andet: Medical Air
Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.
Andet: 10L/min O2
Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.
Eksperimentel: 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
Andet: 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.
Andet: Medical Air
Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.
Andet: 10L/min O2
Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.
Eksperimentel: 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
Andet: 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.
Andet: Medical Air
Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.
Andet: 10L/min O2
Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in PCO2 during hyperoxia at rest
Tidsramme: 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 from baseline to after 10 minutes breathing 10L/min oxygen
Change in PCO2 from rest to end exercise (endurance shuttle walk test)
Tidsramme: 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
Change from baseline to the end of the ESWT, up to 20 minutes

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Transcutaneous partial pressure of CO2 (TcPCO2) during hyperoxia test
Tidsramme: Continuously from baseline to 10 minutes breathing 10L/min oxygen
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
Tidsramme: Continuously during ESWT, up to 20 minutes
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
Tidsramme: Continuously from baseline to 10 minutes breathing 10L/min oxygen
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
Tidsramme: Continuously during ESWT, up to 20 minutes
Breathing frequency during the ESWT measured by ApneaLink Air™ (ResMed)
Continuously during ESWT, up to 20 minutes
Heart rate during endurance shuttle walk test
Tidsramme: Continuously during ESWT, up to 20 minutes
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
Tidsramme: Continuously from baseline to 10 minutes breathing 10L/min oxygen
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
Tidsramme: 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
Change from baseline to the end of the ESWT, up to 20 minutes
Change of inspiratory capacity during endurance shuttle walk test
Tidsramme: Change from baseline to the end of the ESWT, up to 20 minutes
IC measured by SpiroSense (Pari) before and after the ESWT
Change from baseline to the end of the ESWT, up to 20 minutes

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Schön Klinik Berchtesgadener Land

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. juli 2021

Primær færdiggørelse (Forventet)

1. maj 2022

Studieafslutning (Forventet)

1. maj 2022

Datoer for studieregistrering

Først indsendt

4. maj 2021

Først indsendt, der opfyldte QC-kriterier

5. juli 2021

Først opslået (Faktiske)

9. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CO2-Hyperoxia & Exercise

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

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