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临床试验/NCT01506284
NCT01506284已完成不适用

Assessment of Airways Mechanical Properties by Forced Oscillatory Technique (FOT) and Laser Interferometry (LIR) During Anesthesia.

Uppsala University Hospital1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2011年11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
14
试验地点
1
主要终点
Change in respiratory system impedance

研究概览

简要总结

The aims of the present study are:

  1. To evaluate the effect of the induction of anaesthesia and paralysis in terms of changes in oscillatory mechanics parameters
  2. To evaluate the mechanical properties of the respiratory system in terms of input and transfer oscillatory impedance in response to PEEP changes

详细描述

It has been recently shown that respiratory system reactance (Xrs) obtained by the forced oscillation technique (FOT) at 5 Hz is more reliable than dynamic compliance for assessing lung collapse and the effects of lung RMs in a porcine ALI model ( Ref.1,2).

Specifically, Xrs (and its derived variable CX5, the oscillatory compliance at 5 Hz) identifies the minimum positive end-expiratory pressure (PEEP) level required to maintain lung recruitment with high sensitivity and specificity. Moreover, it has been recently demonstrated that Xrs may be used to identify the lowest level of PEEP able to prevent atelectasis and that PEEP setting strategy based on maximizing Xrs is able to limit lung injury compared to oxygenation-based approach in a porcine lavage model of lung injury. ( Ref.3)

Recently, at the biomedical engineering department of Politecnico di Milano measurements of chest wall displacement have been successfully performed by means of an optical sensor realized using a laser self-mixing interferometer (LIR). The advantage of this approach is that it is contact-less, that by deflecting the laser been it is possible to scan any region of the chest wall surface and that it allows to measure also low-frequency vibrations.

Protocol

  1. The baseline pulmonary function will be assessed by spirometry before surgery.
  2. Just before surgery measurements of oscillatory mechanics will be performed at the following stages:

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age >18 years
  • ASA I-II, scheduled for elective surgery requiring general anesthesia
  • signed informed consent

排除标准

  • patient refusal
  • BMI > 35
  • co-existing respiratory disease (COPD, asthma, restrictive lung disease)
  • pregnancy

结局指标

主要结局

Change in respiratory system impedance

时间窗: baseline and 5 minutes of ventilation

FOT measurements: Respiratory system impedance will be computed from the flow and pressure signals measured at the inlet of the tracheal tube. A composite waveform including 5, 11 and 19 Hz will be used as a stimulating signal generated by an A/D-D/A board and amplified by a power amplifier that drives a loudspeaker the output of which is connected to inspiratory line of the ventilator.

次要结局

  • Change in chest wall displacement measured by LIR(baseline and 5 minutes of ventilation)
  • Change in oxygenation (paO2)(baseline and 5 minutes of ventilation)
  • Change in Functional residual capacity (FRC)(baseline and 5 minutes of ventilation)

研究者

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

Peter Kostic

Principal investigator

Uppsala University Hospital

研究点 (1)

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