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临床试验/NCT04758910
NCT04758910
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The Effect of High Flow Oxygen Therapy Via Tracheostomy on Diaphragm Function in Patients With Prolonged Weaning From Mechanical Ventilation

Evangelismos Hospital0 个研究点目标入组 30 人2021年3月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Weaning Failure
发起方
Evangelismos Hospital
入组人数
30
主要终点
Diaphragmatic thickening fraction
最后更新
5年前

概览

简要总结

While the high flow oxygen therapy (HFOT) respiratory support system, delivered through nasal cannulas, has demonstrated clinical benefits on respiratory function, limited data exist on whether such effects are also present in HFOT through tracheostomy. Therefore, the aim of the proposed study is to examine the short-term effects of HFOT as opposed to oxygen therapy via T-piece on diaphragmatic function in tracheostomized patients with prolonged weaning from mechanical ventilation.

详细描述

Critically ill patients who experience difficulties in weaning from the ventilator often undergo tracheostomy. These patients usually undergo spontaneous breathing trials receiving oxygen via T-piece. While the high flow oxygen therapy (HFOT) respiratory support system, delivered through nasal cannulas, has demonstrated clinical benefits on respiratory function, limited data exist on whether such effects are also present in HFOT through tracheostomy. Therefore, we plan to perform a study to examine the short-term effects of HFOT on diaphragmatic function in tracheostomized patients with prolonged weaning from mechanical ventilation. After disconnection from the ventilator, patients will undergo a 30-minute spontaneous breathing trial receiving oxygen either conventionally via T-piece, or by HFOT delivered via tracheostomy, followed by a washout period of 15 min breathing through T-piece and 30 min receiving oxygen with the other modality in a randomized manner. At the start and end of each study period, patients will undergo an assessment through diaphragm ultrasonography, which includes excursion of diaphragmatic dome and thickness of diaphragmatic zone of apposition at end-inspiration and end-expiration. Subsequently, the diaphragmatic thickening fraction will be calculated as the difference between end-inspiratory and end-expiratory thickness divided by end-expiratory thickness. Also. arterial blood gases as well as respiratory rate (RR) and tidal volume (TV) (through a Wright's spirometer) will be measured.

注册库
clinicaltrials.gov
开始日期
2021年3月1日
结束日期
2021年7月30日
最后更新
5年前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

发起方
Evangelismos Hospital
责任方
Principal Investigator
主要研究者

CHRISTINA ROUTSI

Professor in Medicine, National and Kapodistrian University of Athens, Athens, Greece

Evangelismos Hospital

入排标准

入选标准

  • Mechanically ventilated patients with prolonged weaning and tracheostomy

排除标准

  • pregnancy

结局指标

主要结局

Diaphragmatic thickening fraction

时间窗: 30 minutes

Differences in diaphragmatic thickening fraction between high flow oxygen therapy and T-piece will be assessed using bedside ultrasound examination of the diaphragm thickness of diaphragmatic zone of apposition at end-inspiration and end-expiration and subsequent calculation of the difference between end-inspiratory and end-expiratory thickness divided by end-expiratory thickness.

Diaphragmatic function

时间窗: 30 minutes

Differences in diaphragmatic function between high flow oxygen therapy and T-piece will be assessed by diaphragm excursion measurement (in cm) using bedside ultrasound examination of the diaphragm.

次要结局

  • Respiratory frequence(30 minutes)
  • Tidal volume(30 minutes)

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