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CO2-Patterns During Hyperoxia and Physical Exercise in COPD

13 luglio 2021 aggiornato da: 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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

55

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Germania
      • Schönau am Königssee, Germania, 83471
        • Reclutamento
        • Klinikum Berchtesgadener Land, Schön Kliniken
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Altro: 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.
Altro: Medical Air
Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.
Altro: 10L/min O2
Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.
Sperimentale: 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
Altro: 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.
Altro: Medical Air
Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.
Altro: 10L/min O2
Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.
Sperimentale: 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
Altro: 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.
Altro: Medical Air
Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.
Altro: 10L/min O2
Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in PCO2 during hyperoxia at rest
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Transcutaneous partial pressure of CO2 (TcPCO2) during hyperoxia test
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Schön Klinik Berchtesgadener Land

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 luglio 2021

Completamento primario (Anticipato)

1 maggio 2022

Completamento dello studio (Anticipato)

1 maggio 2022

Date di iscrizione allo studio

Primo inviato

4 maggio 2021

Primo inviato che soddisfa i criteri di controllo qualità

5 luglio 2021

Primo Inserito (Effettivo)

9 luglio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 luglio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 luglio 2021

Ultimo verificato

1 luglio 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CO2-Hyperoxia & Exercise

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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