跳至主要内容
临床试验/NCT02259335
NCT02259335Unknown不适用

A Pilot Study on the Use of Extracorporeal CO2 Removal During the Weaning Process From Mechanical Ventilation

IRCCS Azienda Ospedaliero-Universitaria di Bologna4 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
4
主要终点
passing a weaning trial using a T-piece method

研究概览

简要总结

Weaning from invasive mechanical ventilation is one of the major clinical problem especially ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania.

The aim of this pilot feasibility and safety trial is to assess the possibility of shorten the duration of mechanical ventilation using a device able to remove CO2 and theoretically able to allow therefore the praecox extubation

详细描述

Weaning from invasive mechanical ventilation is one of the major clinical problem especially ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania. Up to 60% of the ventilatory time is devoted in these patients to the process of weaning.

These patients very often fail several weaning attempt, when a T-piece trial method is used. In this case they are also very likely to require tracheotomy.

In this study we will enroll those still hypercapnic patients fitting the criteria of readiness to be wean (i.e. clinical stability, normal sensorium and good cough reflex) and failing a T-piece trail because of a rise in PaCO2 (>20% from baseline) and/or a rapid shallow breathing index (f/VT)> 100.

After the unsuccessful trial they will be reconnected to the ventilator and they will repeat hours later the same T-piece trial once the extracorporeal CO2 removal device (DeCap) will be connected via a double lumen catheter in the femoral vein.

The investigators aim to verify whether using the DeCap) the investigators will be able to avoid at the end of the T-piece trial the criteria of failure. If so, the patient will be extubated and DeCap will be continued when all of the following were achieved for at least 12 hours: respiratory rate less than 25 breaths/min; pH greater than 7.35; Paco2 less than 20% of the baseline value; and absence of use of the accessory muscles or paradoxical abdominal movements.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients meeting the criteria for readiness to be weaned (i.e. clinical stability, FiO2<50%, normal sensorium, body temperature < 38 and satisfactory cough reflex)
  • Failing a T-piece trial after 1 hour or before for a rise in PaCO2>20% from baseline and with f/VT ratio >100

排除标准

  • Patients NOT meeting the criteria for readiness to be weaned
  • Patients succeeding a T-piece trial

结局指标

主要结局

passing a weaning trial using a T-piece method

时间窗: 1 hour

avoiding to reach the criteria of weaning failure

weaning success

时间窗: 48 hours

avoiding reintubation after removal of DeCap

次要结局

  • Physiological variables (i.e. Arterial Blood Gases, vitals and dyspnea)(48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

dr. Stefano Nava

Professor of Respiratory Medicine

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (4)

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