跳至主要内容
临床试验/NCT01337271
NCT01337271已完成不适用

Performance of Neurally Adjusted Ventilatory Assist (NAVA) During an Spontaneous Breathing Trial

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
rate of success on the spontaneous breathing trial

研究概览

简要总结

The purpose of this study is to compare a new mode of mechanical ventilation (NAVA, or Neurally adjusted Ventilatory assist) with a traditional mode (Pressure Support ventilation) on its the ability to detect patients ready for extubation (liberation from mechanical ventilation).

详细描述

Patients under mechanical ventilation who are suspected to be recovered and ready to return to spontaneous ventilation often undergo an spontaneous breathing trial (SBT) before extubation and liberation from mechanical ventilation. During the test, which lasts from 30 minutes to 2 hours , the patient receives minimal support from the ventilator, and the ICU team observes if the patient develops any signs or symptoms of discomfort or respiratory distress. If the patient tolerates the test, he or she is considered ready for extubation. The Neurally Adjusted Ventilatory Assist (NAVA) is a new mode of ventilation, shown to improve patient-ventilator synchrony. It has not been tested during SBTs. Our objective is to compare the performance of NAVA with the commonly used Pressure Support ventilation, during an SBT. Patients considered to be ready for an SBT by the ICU team will undergo two SBTs in random order: one in pressure support, and the other on NAVA, with a 1-hour interval between the tests. Ventilatory parameters and patient-ventilator interaction variables will be compared among the two tests.

This study will help us understand if NAVA can be used during an SBT, which might be important for patients who are being ventilated with NAVA before the SBT is suggested, especially those how present a high asynchrony rate when ventilated with Pressure Support Mode.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Screening
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • mechanical ventilation for more than 48 hours
  • Considered ready for an spontaneous breathing trial by the ICU team
  • informed consent for participation on the study signed by a family member

排除标准

  • age < 18yrs
  • pregnancy
  • facial trauma or burns that might interfere with the esophageal catheter placement
  • nasal pathologies that prevent adequate placement of the catheter
  • esophageal varices or gastroesophageal bleeding in the past 30 days

研究组 & 干预措施

PSV

Active Comparator

干预措施: SBT- PSV (Procedure)

PSV

Active Comparator

干预措施: SBT - NAVA (Procedure)

NAVA

Experimental

干预措施: SBT- PSV (Procedure)

NAVA

Experimental

干预措施: SBT - NAVA (Procedure)

结局指标

主要结局

rate of success on the spontaneous breathing trial

时间窗: 30 minutes, or earlier (if the SBT is interrupted for intolerance), i.e., at the end of the spontaneous breathing trial

The ICU team will observe the patient during the spontaneous breathing trial, and use standard objective (blood gases) and subjective (including respiratory rate, tidal volume, comfort, hemodynamic variables) variables to determine if the patient tolerates the SBT and therefore is ready for discontinuation from mechanical ventilation

次要结局

  • Extubation failure rate(48 hours after extubation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Performance of Neurally Adjusted Ventilatory Assist... | 临床试验