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Study Comparing Two Ventilation Modes NAVA (Neurally Adjusted Ventilatory Assist) Mode and Spontaneous Breathing With Inspiratory Pressure Support (IPS) Mode in Consecutive Patients Hospitalized for Acute Respiratory Failure Requiring Mechanical Ventilation With Endotracheal Tube.

2013年12月17日 更新者:Clinact

ZEPHYR: Multicenter, Prospective, Randomized, Open-label Study in Consecutive Patients Hospitalized for Acute Respiratory Failure Requiring Mechanical Ventilation With Endotracheal Tube. This Study Compared Two Ventilation Modes: NAVA Mode and Spontaneous Breathing With Inspiratory Pressure Support (the Latter is Considered as the Reference Ventilation Mode).

This is a multicenter, prospective, randomized, open-label study which compared two ventilation modes: spontaneous NAVA mode and spontaneous breathing with IPS mode (the latter is considered as the reference ventilatory mode) in patients admitted to the ICU for acute respiratory failure and ventilated with an endotracheal tube. NAVA mode allows to minimize patient-ventilator disharmony with acceptable tolerance and to preserve spontaneous ventilation.

研究概览

地位

完全的

研究类型

介入性

注册 (实际的)

129

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Alpes Maritimes
      • Nice、Alpes Maritimes、法国、06202
        • Hôpital l'Archet 1
    • Gironde
      • Bordeaux、Gironde、法国、33076
        • Hopital Pellegrin
      • Pessac、Gironde、法国、33604
        • Groupe Hospitalier Sud - Hôpital Haut-Leveque - Maison du Haut-Leveque
    • Haute Vienne
      • Limoges、Haute Vienne、法国、87042
        • Hôpital Dupuytren
    • Herault
      • Montpellier、Herault、法国、34295
        • Hopital Saint-Eloi - CHU MONTPELLIER
    • Ile de France
      • Paris、Ile de France、法国、75651
        • Hopital de la Pitie Salpetriere
    • Maine Et Loire
      • Angers、Maine Et Loire、法国、49933
        • Hopital Larrey- CHU D'ANGERS
    • Normandie
      • Caen、Normandie、法国、14000
        • Hopital de la Cote de Nacre - CHU de CAEN
    • Puy de Dome
      • Clermont Ferrand、Puy de Dome、法国、63100
        • Hopital D'Estaing
    • Rhone Alpes
      • Lyon、Rhone Alpes、法国、69004
        • Hôpital de La Croix Rousse
      • Lyon、Rhone Alpes、法国、69495
        • Centre Hospitalier Lyon Sud

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patient ventilated with endotracheal tube for more than 24 hours
  • Return for at least 30 minutes to spontaneous ventilation allowing IPS with a level of pressure support <30 cm H2O;
  • Level of sedation =< 4 on the Ramsay scale in the absence of medical decision to increase the level of sedation;
  • Fraction of inspired oxygen (FiO 2) =< 50% with a positive end-expiratory pressure (PEEP) =< 8 cm H2O;
  • Absence of administration of high-dose vasopressor therapy defined by:

    1. norepinephrine > 0.3 mcg / kg / min;
    2. dopamine > 10 mcg / kg / min;
  • Estimated duration of mechanical ventilation > 48h00

Exclusion Criteria:

  • Contraindication to the implementation of the NAVA endotracheal tube, ie any contraindication to the implementation of a gastric tube or to the repositioning of a tube already in place:

    1. Recent gastrointestinal suture ;
    2. Esophageal varices rupture with gastrointestinal bleeding within 4 days prior to inclusion;
  • Therapeutic limitation or active treatment discontinuation;
  • Pregnant women;
  • Minors;
  • Protected adults;
  • Patient already included in the study;

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:spontaneous NAVA mode
有源比较器:Inspiratory pressure support (IPS)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Evaluate the benefit of NAVA mode as compared to IPS mode in terms of duration of spontaneous ventilation 48 hours after inclusion.
大体时间:Continuous recording during 48 hours following the intubation
The time spent in different modes of spontaneous ventilation (NAVA, IPS) and controlled ventilation (VAC controlled pressure) will be measured. The primary endpoint will be the proportion of patients remaining in spontaneous ventilation after the first 48 hours.
Continuous recording during 48 hours following the intubation

次要结果测量

结果测量
措施说明
大体时间
Reduction of patient / ventilator disharmony, measured during the first 48 hours with the disharmony index
大体时间:Continuous recording during the first 48 hours
Continuous recording during the first 48 hours
Real-time spent in NAVA mode and frequency of returns in a controlled mode (controlled ventilation VAC).
大体时间:Continuous recording during the first 48 hours
Feasibility of the initiation of mechanical ventilation in NAVA mode and feasibility of prolonged mechanical ventilation in NAVA mode
Continuous recording during the first 48 hours
Earnings on the "breathing comfort"
大体时间:Continuous recording during the first 48 hours
Continuous recording during the first 48 hours
Earnings on sleep architecture
大体时间:Continuous recording during the first 48 hours
Total sleep time; Number of arousals per hour; Duration of stage IV sleep ; Duration of Rapid Eye Movement (REM) sleep.
Continuous recording during the first 48 hours
Tolerance
大体时间:Continuous for the duration of ICU stay, an expected maximum of 14 days
  • Adverse events associated with the use of the device.
  • Incidence of ventilator-acquired pneumonia.
  • Duration of ICU stay.
  • Duration of hospital stay.
  • Mortality in the ICU.
  • Hospital mortality.
Continuous for the duration of ICU stay, an expected maximum of 14 days

其他结果措施

结果测量
措施说明
大体时间
Number of implementation failure of the NAVA endotracheal tube.
大体时间:For each patient, the success or failure of the endotracheal tube implementation will be evaluated, this for the entire duration of the study estimated to 18 months
For each patient, the success or failure of the endotracheal tube implementation will be evaluated, this for the entire duration of the study estimated to 18 months
Number and duration of automatic switch into IPS mode
大体时间:Continuous recording until extubation or D14 maximum
Continuous recording until extubation or D14 maximum
Number of Permanent discontinuation of NAVA ventilation mode
大体时间:Continuous recording during the first 48 hours
Continuous recording during the first 48 hours
Comfort of the device measured by a visual analog scale.
大体时间:At the extubation or at D14 maximum
Tolerance of the device
At the extubation or at D14 maximum
Side effects associated with the use of the system
大体时间:Continuous for the duration of ICU stay, an expected maximum of 14 days
Device movements Endotracheal tube obstruction Lesion of the oral or nasal mucosa
Continuous for the duration of ICU stay, an expected maximum of 14 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年1月1日

初级完成 (实际的)

2013年8月1日

研究完成 (实际的)

2013年8月1日

研究注册日期

首次提交

2013年12月11日

首先提交符合 QC 标准的

2013年12月17日

首次发布 (估计)

2013年12月23日

研究记录更新

最后更新发布 (估计)

2013年12月23日

上次提交的符合 QC 标准的更新

2013年12月17日

最后验证

2013年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • N° 2011-001
  • 2011-A00559-32 (其他标识符:ANSM)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

NAVA endotracheal tube的临床试验

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