拡張ARDS-J食道内圧研究
基本情報
- NCT ID
- NCT06734988
- ステータス
- 募集中
- 試験のフェーズ
- -
- 試験タイプ
- 観察
- 目標被験者数
- 100
- 治験依頼者名
- Sapporo Medical University
概要
Background: Acute respiratory distress syndrome (ARDS) patients require careful assessment before extubation to prevent failure, which is associated with poor outcomes. While current guidelines recommend weaning protocols, these are based on general respiratory failure studies rather than ARDS-specific data. Esophageal pressure (Pes) measurement provides direct assessment of inspiratory effort but is rarely utilized clinically. Objectives: This Japanese sub-study of EXTEND ARDS aims to evaluate whether: 1. ΔPes measurements during spontaneous breathing trials (SBT) can predict SBT failure 2. ΔPes measurements post-extubation can predict 48-hour extubation failure Methods: This prospective observational study will be conducted in Japanese ICUs. Esophageal pressure will be measured using standardized Nutrivent balloons (4mL volume) with Hamilton ventilators. Balloon placement in the lower third of the esophagus will be confirmed by cardiac artifacts and chest X-ray. ΔPes will be calculated as the difference between end-expiratory and peak inspiratory esophageal pressure, excluding esophageal contractions. Significance: This study addresses a knowledge gap regarding the utility of esophageal pressure monitoring in ARDS patients during mechanical ventilation weaning. Findings may help optimize extubation timing and improve patient outcomes through objective physiological measurements.
対象疾患
依頼者(Sponsor)
実施施設 (1)
札幌医科大学附属病院
Sapporo, Hokkaido, Japan(RECRUITING)