Accuracy of Physical Examination for Assessing Inspiratory Effort During Assisted Ventilation
調査の概要
状態
詳細な説明
Insufficient or excessive respiratory effort during assisted ventilation contributes to diaphragm injury and patient self-inflicted lung injury (P-SILI), both of which worsen outcomes. Patients in the transition phase from controlled ventilation to assisted modes are particularly vulnerable because persistent lung injury may drive elevated respiratory effort, pendelluft, and large swings in alveolar pressure. One of the main goals of assisted ventilation is therefore to maintain effort within a physiological range that avoids both over- and under-assistance.
During pressure support ventilation (PSV), direct measurement of respiratory effort requires esophageal pressure monitoring, which is rarely feasible in routine care. Other noninvasive approaches, such as diaphragm ultrasound, lack reproducibility and cannot provide continuous monitoring. Airway occlusion pressure has shown promise for identifying both insufficient and excessive effort, but its performance varies across ventilator models. Additional indices, such as the maximal negative swing of airway pressure during end-expiratory occlusion (∆Pocc), or the pressure-muscle index (PMI), are limited by ventilator constraints.
In clinical practice, respiratory effort is usually judged clinically at the bedside. However, the accuracy of clinical examination for detecting abnormal effort has never been validated. The investigators hypothesize that bedside clinical assessment is unreliable and may expose patients to inappropriate levels of assistance. The primary aim of this investigation was to determine the accuracy of clinical examination in diagnosing abnormal respiratory effort during PSV.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Créteil、フランス
- Hopital Henri Mondor
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- patients mechanically ventilated for at least 48 hours
- switched to pressure support ventilation within the previous 48 hours
Exclusion Criteria:
- pregnancy
- legal protection status
- refusal by the patient or relatives to participate
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
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 |
|---|---|---|
|
Diagnostic performance (sensitivity, specificity) of the clinical evaluation in diagnosing excessive respiratory effort and insufficient respiratory effort
時間枠:Baseline
|
The physician in charge of the patient will be asked to categorize the patient respiratory effort as normal, insufficient or excessive, based on his/her clinical evaluation. Esophageal pressure will be recorded at the same time, using an esophageal catheter. Esophageal pressure time product will then be computed and considered the reference standard for respiratory effort quantification. Sensitivity and Specificity of the clinical evaluation to diagnose excessive or insufficcient effort will be computed |
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mortality
時間枠:Day 28
|
Mortality
|
Day 28
|
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 (実際)
研究の完了 (実際)
試験登録日
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
詳しくは
本研究に関する用語
その他の研究ID番号
- CLINASSEF
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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