Calibre vs. COSMED
2026年6月16日 更新者：Duke University
Correlation of Cardiopulmonary Exercise Testing (CPET) VO2 Max Parameters Between the Calibre Device and COSMED Metabolic Cart
This study evaluates agreement between the Calibre device and the COSMED Quark CPET system for measurement of cardiorespiratory fitness parameters during maximal exercise testing in adults aged 18-55 years.
調査の概要
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
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
- 大人
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Age 18-55
- Able to speak English
- Able to provide informed consent
Exclusion Criteria:
- Acute myocardial infarction
- Unstable angina
- Syncope
- Uncontrolled asthma
- Arterial desaturation at rest on room air <85%
- Severe untreated arterial hypertension at rest (>200 mm Hg systolic, >120 mm Hg diastolic)
- Significant pulmonary hypertension
- Active thrombosis of the lower extremity, unless treated for at least 2 weeks prior to participation.
- Within 2 weeks of acute symptomatic pulmonary embolus
- Considered inappropriate to participate by Principal Investigator
- Previously experienced a heart attack
- Pregnancy
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：他の
- 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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Calibre First Sequence
Participants undergo cardiopulmonary exercise testing using the investigational Calibre device during Visit 1, followed by testing with the COSMED Quark CPET reference system during Visit 2 (at least 2 days later).
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Investigational wearable facemask device with integrated sensors for breath-by-breath measurement of respiratory gas exchange and ventilatory parameters during cardiopulmonary exercise testing, evaluated against the COSMED Quark CPET reference system.
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実験的：COSMED First Sequence
Participants undergo cardiopulmonary exercise testing using the COSMED Quark CPET reference system during Visit 1, followed by testing with the investigational Calibre device during Visit 2 (at least 2 days later).
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FDA-cleared cardiopulmonary exercise testing (CPET) metabolic cart used as the reference comparator for measurement of respiratory gas exchange and ventilatory parameters during ramp cycle ergometry.
Participants wear a facemask connected to the system for breath-by-breath measurement of oxygen consumption (VO2), carbon dioxide production (VCO2), minute ventilation (VE), anaerobic threshold, and ventilatory efficiency during maximal exercise testing.
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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 |
|---|---|---|
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VO₂ peak correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED
時間枠：During CPET testing across Visit 1 and Visit 2, up to 7 days.
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VO₂ peak measured during CPET will be compared between devices using Pearson or Spearman correlation coefficient, depending on data distribution.
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During CPET testing across Visit 1 and Visit 2, up to 7 days.
|
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VO₂ peak agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED
時間枠：During CPET testing across Visit 1 and Visit 2, up to 7 days.
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VO₂ peak measured during CPET will be compared between devices using Bland-Altman analysis to estimate average bias and limits of agreement.
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During CPET testing across Visit 1 and Visit 2, up to 7 days.
|
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Anaerobic threshold correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED
時間枠：During CPET testing across Visit 1 and Visit 2, up to 7 days
|
Anaerobic threshold measured during CPET will be compared between devices using Pearson or Spearman correlation coefficient, depending on data distribution.
|
During CPET testing across Visit 1 and Visit 2, up to 7 days
|
|
Anaerobic threshold agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED
時間枠：During CPET testing across Visit 1 and Visit 2, up to 7 days
|
Anaerobic threshold measured during CPET will be compared between devices using Bland-Altman analysis to estimate average bias and limits of agreement.
|
During CPET testing across Visit 1 and Visit 2, up to 7 days
|
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VE/VCO₂ correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED
時間枠：During CPET testing across Visit 1 and Visit 2, up to 7 days
|
Ventilatory equivalent for carbon dioxide (VE/VCO₂) measured during CPET will be compared between devices using Pearson or Spearman correlation coefficient, depending on data distribution.
|
During CPET testing across Visit 1 and Visit 2, up to 7 days
|
|
VE/VCO₂ agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED
時間枠：During CPET testing across Visit 1 and Visit 2, up to 7 days
|
Ventilatory equivalent for carbon dioxide (VE/VCO₂) measured during CPET will be compared between devices using Bland-Altman analysis to estimate average bias and limits of agreement.
|
During CPET testing across Visit 1 and Visit 2, up to 7 days
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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
捜査官
- 主任研究者：David MacLeod, M.B.B.S.、Duke University
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 (推定)
2026年9月1日
一次修了 (推定)
2027年7月1日
研究の完了 (推定)
2027年7月1日
試験登録日
最初に提出
2026年5月5日
QC基準を満たした最初の提出物
2026年5月12日
最初の投稿 (実際)
2026年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月17日
QC基準を満たした最後の更新が送信されました
2026年6月16日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。