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临床试验/NCT01610960
NCT01610960已完成不适用

Comparison of Helmet NEXT, Helmet Standard and Facemask for Noninvasive Ventilation: a Physiological Study in Healthy Volunteers

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Work of breathing

研究概览

简要总结

Noninvasive ventilation (NIV) is a well established, safe, and effective technique in improving gas exchange while reducing dyspnea and inspiratory effort in patients with either hypoxemic and hypercapnic acute respiratory failure (ARF) and averts the risk secondary to endotracheal intubation.Crucial factors for NIV success, in any forms of respiratory failure, are the tolerance to the interface used and the ability of the interface to unload inspiratory-muscle. Helmet is better tolerated over time, allowing continuous application of NIV for longer periods, while face mask has been proved to be more efficient at iso-support in unloading the respiratory muscles and improving patient-ventilator synchrony. Helmet NEXT (CaStar, NIV model, Starmed, Mirandola, Italy) is a novel type of helmet with a better compliant wall, that avoid the use of armpit braces potentially improving, compared to the standard helmet, both pressurization and patient-ventilator interaction and tolerance. The objective of this study is to compare the effects of NIV delivered via face mask, standard helmet, and NEXT helmet in terms of work of breathing, patient-ventilator interaction, and comfort.

详细描述

16 Healthy volunteers will be enrolled. They will be ventilated with non invasive ventilation. The Work of breathing, ventilator/patient asynchrony, and ventilatory comfort produced between face mask, Helmet and NEXT helmet will be compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers

排除标准

  • contraindications for nasogastric tube placement
  • Respiratory disease
  • Pregnancy
  • No French health insurance

结局指标

主要结局

Work of breathing

时间窗: during the single visit study (day 1)

To estimate the work of breathing, we will determine the swings in transdiaphragmatic pressure (Pdi) and the transdiaphragmatic pressure-time product (PTPdi)

次要结局

  • Ventilatory comfort(during the single visit study (day 1))
  • Patient-ventilator asynchronies(during the single visit study (day 1))
  • Ventilatory parameters(during the single visit study (day 1))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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