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CO2-Patterns During Hyperoxia and Physical Exercise in COPD

2021年7月13日 更新者：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

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (予想される)

55

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • ドイツ
      • Schönau am Königssee、ドイツ、83471
        • 募集
        • Klinikum Berchtesgadener Land, Schön Kliniken
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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
他の：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.
他の：Medical Air
Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.
他の：10L/min O2
Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.
実験的：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
他の：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.
他の：Medical Air
Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.
他の：10L/min O2
Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.
実験的：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
他の：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.
他の：Medical Air
Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.
他の：10L/min O2
Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in PCO2 during hyperoxia at rest
時間枠：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)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Transcutaneous partial pressure of CO2 (TcPCO2) during hyperoxia test
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Schön Klinik Berchtesgadener Land

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年7月13日

一次修了 (予想される)

2022年5月1日

研究の完了 (予想される)

2022年5月1日

試験登録日

最初に提出

2021年5月4日

QC基準を満たした最初の提出物

2021年7月5日

最初の投稿 (実際)

2021年7月9日

学習記録の更新

投稿された最後の更新 (実際)

2021年7月14日

QC基準を満たした最後の更新が送信されました

2021年7月13日

最終確認日

2021年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CO2-Hyperoxia & Exercise

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • ICF

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