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临床试验/NCT03758547
NCT03758547Unknown不适用

Physiological Effects of the Application of Secretion Removal Device in Invasively Ventilated Patients

IRCCS Azienda Ospedaliero-Universitaria di Bologna0 个研究点目标入组 20 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
主要终点
Changes in passive respiratory mechanics

研究概览

简要总结

In this study the investigators will assess the effects of secretion removal on "noninvasive" respiratory mechanics, in deeply sedated mechanically ventilated patients All the mechanically ventilated patients will be submitted to the recording of compliance and resistance at baseline (time0), immediately after the application of 10 cycles alternating 30 cmH20 during expiration and -30 cmH20 during exhalation (time1). Afterward the patients will undergo an additional trail using the so called "percussion" technique, to assess any synergic effect of this procedure (time2)

详细描述

In this observational study, the investigators will assess the effects of two secretion removal techniques on passive respiratory mechanics, in patients undergoing invasive mechanical ventilation.

Consecutive patients will undergo 3 sequential assessments at time0 (baseline), at time1 after the application of of 10 cycles alternating 30 cmH20 during expiration and -30 cmH20 during exhalation and finally after a 20 sec application of a "percussion technique".

Protocol:

The patients will be ventilated without PEEP and sedated with a benzodiazepine infusion to produce complete relaxation and adaptation to the ventilator, as assessed by the complete absence of spontaneous efforts, so that there was no change in inspiratory flow rate, tidal volume, or respiratory rate during the three measurement periods.

Airway pressure (Paw) and flow (V) will be measured continuously throughout the respiratory cycle with the transducer and expiratory tidal volume will obtained by electrical integration of the flow signal.

研究设计

研究类型
Interventional
干预模型
Sequential
主要目的
Treatment
盲法
None

盲法说明

patients deeply sedated and therefore not conscious

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • consecutive ventilated and intubated patients
  • age> 18 yrs
  • Sign inform consent
  • clinical indication for secretion removal from the endotracheal tube

排除标准

  • tracheotomy
  • bullous emphysema
  • pneumothorax

研究组 & 干预措施

in-exufflator and percussion technique

Experimental

assess the physiological effects, of a "common" daily practice of secretion removal in intubated patients, that are: in-exufflator technique and percussion technique

干预措施: in-exufflator technique (Device)

in-exufflator and percussion technique

Experimental

assess the physiological effects, of a "common" daily practice of secretion removal in intubated patients, that are: in-exufflator technique and percussion technique

干预措施: percussion technique (Device)

结局指标

主要结局

Changes in passive respiratory mechanics

时间窗: immediate

RESPIRATORY MECHANICS is monitored using the end-expiratory and end inspiratory technique, obtained pressing the hold command on the ventilator

次要结局

  • changes in arterial blood gases(immediate)

研究者

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

dr. Stefano Nava

Chief of Respiratory and Critical Care unit

IRCCS Azienda Ospedaliero-Universitaria di Bologna

相似试验

Effects of Secretion Removal in Ventilated Patients | 临床试验