Comparison of Arterial and Capillary Blood Gas Analyses in Patients With Respiratory Distress Due to COPD or APE (GAZOCAP)
The assessment of gas exchange is crucial for the management of patients suffering from respiratory distress due to an exacerbation of chronic obstructive pulmonary disease (COPD) or cardiogenic acute pulmonary edema (APE). These measurements are used by physicians to determine the need for noninvasive ventilation (NIV) as well as to evaluate its effectiveness and to decide whether to continue the treatment.
Arterial blood gas analysis is currently the gold standard for the measurement of these gas exchanges, though invasive, painful and risky (failure risks and possible local complications). Capillary blood gas analysis, which consists in collecting a blood drop from the ear or the finger by capillarity after punction, could represent a less invasive alternative. However, data comparing the performances of arterial and capillary blood gas analysis in the context of respiratory distress requiring a NIV remain limited.
This study is based on the hypothesis that capillary blood gas analysis can perform as well as arterial blood gas analysis. It is aimed at comparing values obtained from arterial and capillary blood gas analyses from patients with respiratory distress and requiring a NIV due to an exacerbation of COPD or cardiogenic APE.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Nathalie Ducot, MD-PhD
- 電話番号：+33 (0)4 92 03 32 42
- メール：ducot.n@chu-nice.fr
研究連絡先のバックアップ
- 名前：Charlotte Monge
- 電話番号：+33 (0)7 87 51 25 93
- メール：monge.c@chu-nice.fr
研究場所
-
-
-
Nice、フランス、06000
- 募集
- CHU de Nice
-
コンタクト：
- Nathalie Ducot, MD-PhD
- 電話番号：+33 (0)4 92 03 32 42
- メール：ducot.n@chu-nice.fr
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients older than 18 years old
- Patients admitted in the emergency care unit with an exacerbation of COPD or a cardiogenic APE requiring a non-invasive ventilation (i.e. for COPD patients pH< 7.35, for APE patients: PCO2 > 45 mmHg)
- Patients affiliated to a social security system
Exclusion Criteria:
- Patients for which a non-invasive ventilation was initiated upon pre-hospital care
- Contraindication for non-invasive ventilation
- Patients for which non-invasive ventilation is not indicated
- Patients for which capillary or arterial blood gas analyses are impossible
- Adults subject to legal guardianship (guardianship, conservatorship)
- Pregnant women
- Patients with a congenital heart disease
研究計画
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：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Respiratory distress arm requiring a noninvasive ventilation
|
The intervention consists in carrying out arterial, veinous and capillary blood gas analyses before submitting the patient to noninvasive ventilation (5 minutes will separate each sampling). Data from these samplings will be recorded. 1 hour after the implementation of the noninvasive ventilation, patients will once again undergo arterial, veinous and capillary samplings for blood gas analyses. Respiratory parameters will be recorded as well at the onset of the noninvasive ventilation and one hour after its start. |
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 |
|---|---|---|
|
Agreement between carbon dioxide pressure (PCO2) values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
時間枠：Baseline (once the patient arrives at the emergency care unit and is included in the study)
|
Agreement between arterial and capillary pCO₂ measurements, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement |
Baseline (once the patient arrives at the emergency care unit and is included in the study)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Agreement between pH values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE
時間枠：Baseline (once the patient arrives at the emergency care unit and is included in the study)
|
Agreement between pH values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement. |
Baseline (once the patient arrives at the emergency care unit and is included in the study)
|
|
Agreement between bicarbonate concentration values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
時間枠：Baseline (once the patient arrives at the emergency care unit and is included in the study)
|
Agreement between bicarbonate concentration values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement. |
Baseline (once the patient arrives at the emergency care unit and is included in the study)
|
|
Agreement between base concentration values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
時間枠：Baseline (once the patient arrives at the emergency care unit and is included in the study)
|
Agreement between base concentration values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement |
Baseline (once the patient arrives at the emergency care unit and is included in the study)
|
|
Agreement between PCO2 values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
時間枠：One hour after initiation of non-invasive ventilation.
|
Agreement between PCO2 values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement |
One hour after initiation of non-invasive ventilation.
|
|
Agreement between pH values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
時間枠：One hour after initiation of non-invasive ventilation.
|
Agreement between pH values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement. |
One hour after initiation of non-invasive ventilation.
|
|
Agreement between bicarbonate concentration values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
時間枠：One hour after initiation of non-invasive ventilation.
|
Agreement between bicarbonate concentration values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement |
One hour after initiation of non-invasive ventilation.
|
|
Agreement between base concentration values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
時間枠：One hour after initiation of non-invasive ventilation.
|
Agreement between base concentration values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement. |
One hour after initiation of non-invasive ventilation.
|
|
Agreement between PCO2 values obtained from veinous and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
時間枠：Baseline (once the patient arrives at the emergency care unit and is included in the study).
|
Agreement between PCO2 values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement |
Baseline (once the patient arrives at the emergency care unit and is included in the study).
|
|
Agreement between pH values obtained from veinous and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
時間枠：Baseline (once the patient arrives at the emergency care unit and is included in the study).
|
Agreement between pH values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement. |
Baseline (once the patient arrives at the emergency care unit and is included in the study).
|
|
Agreement between bicarbonate concentration values obtained from veinous and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
時間枠：Baseline (once the patient arrives at the emergency care unit and is included in the study).
|
Agreement between bicarbonate concentration values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement |
Baseline (once the patient arrives at the emergency care unit and is included in the study).
|
|
Agreement between base concentration values obtained from veinous and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
時間枠：Baseline (once the patient arrives at the emergency care unit and is included in the study).
|
Agreement between base concentration values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement |
Baseline (once the patient arrives at the emergency care unit and is included in the study).
|
|
Agreement between PCO2 values obtained from veinous and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
時間枠：One hour after initiation of non-invasive ventilation.
|
Agreement between PCO2 values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement |
One hour after initiation of non-invasive ventilation.
|
|
Agreement between pH values obtained from veinous and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
時間枠：One hour after initiation of non-invasive ventilation.
|
Agreement between pH values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement |
One hour after initiation of non-invasive ventilation.
|
|
Agreement between bicarbonate concentration values obtained from veinous and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
時間枠：One hour after initiation of non-invasive ventilation.
|
Agreement between Bicarbonate concentration values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement |
One hour after initiation of non-invasive ventilation.
|
|
Agreement between base concentration values obtained from veinous and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
時間枠：One hour after initiation of non-invasive ventilation.
|
Agreement between base concentration values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement |
One hour after initiation of non-invasive ventilation.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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追加の関連 MeSH 用語
その他の研究ID番号
- 25-PP-13
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