跳至主要内容
临床试验/NCT03326414
NCT03326414Unknown不适用

Influence of Different PEEP Levels and Different Tidal Volumes on Regional Pulmonary Function in Patients Undergoing Robot Assisted Prostatectomy Detected by Electrical Impedance Tomography

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018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
40
试验地点
1
主要终点
Change of "dependent silent spaces" (DSS) and "non-dependent silent spaces" (NSS)

研究概览

简要总结

Mechanical ventilation is indispensable for most of surgical interventions but can induce lung injury even in pulmonary healthy patients. This can lead to postoperative pulmonary complications. These adverse effects could be prevented by a better monitoring of intraoperative lung function. Electrical impedance tomography is able to visualize aeration within the lung in real time.

The planned study investigates the influence of different levels of positive endexspiratory pressure and different tidal volumes on the aeration.

详细描述

Available perioperative parameters to set mechanical ventilation parameters represent only global lung function. But to reduce postoperative pulmonary complications induced by mechanical ventilation a better monitoring of intraoperative lung function seems to be crucial, that provides more regional information of lung collapse or over distention.

By application of small currents via electrodes around the thorax and measuring of the resultant resistance the electrical impedance tomography (EIT) can determine the level of aeration of the lung in a cross sectional plane. The EIT device used in this study calculates the percentage of the investigated lung area that can be defined as over distended or collapsed respectively. In these sections the change of resistance within a respiration cycle is reduced compared to well ventilated areas are therefore called silent spaces. Silent spaces located ventral are termed non-dependent (NSS) and silent spaces located dorsal are termed dependent (DSS). Based on this information the clinician is able to set the respirator in a more lung protective manor.

To better understand the influence of positive endexspiratory pressure (PEEP) and tidal volume (Vt) on reginal lung function we are going to carry out the presented study.

40 patients undergoing robot assisted prostatectomy should be enrolled in a study that consists of two phases. In the first phase 20 patients are ventilated with constant PEEP (10mbar) and in ten patients each the Vt is set to 5 or 12ml/kg ideal body weight. In the second phase in further 20 patients the Vt is set to 8ml/ kg ideal bodyweight and the PEEP is 3 or 12mbar in one half of the patients. Under the different ventilation settings the NSS and DSS, the oxygenation index and lung compliance will be investigated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • over 18 years of age
  • scheduled for robot assisted prostate ectomy

排除标准

  • body mass index >35 kg/m²
  • chronic obstructive lung disease (GOLD III or IV)
  • obstructive sleep apnoe syndrome
  • planned or unplanned admission to intensive care unit for prolonged ventilation
  • mechanical ventialtion within the last 30 days
  • lung operation in the past
  • other lung disease that impairs activity

研究组 & 干预措施

Constant PEEP - low tidal volume

Other

PEEP is 10mbar, tidal volume is set to 4-5ml/kg IBW

干预措施: Constant PEEP - low tidal volume (Procedure)

Constant PEEP - high tidal volume

Other

PEEP is 10mbar, tidal volume is set to 8-10ml/kg IBW

干预措施: Constant PEEP - high tidal volume (Procedure)

constant tidal volume - low PEEP

Other

tidal volume is 8ml/kg IBW, PEEP is set to 3mbar

干预措施: constant tidal volume - low PEEP (Procedure)

constant tidal volume - high PEEP

Other

tidal volume is 8ml/kg IBW, PEEP is set to 12mbar

干预措施: constant tidal volume - high PEEP (Procedure)

结局指标

主要结局

Change of "dependent silent spaces" (DSS) and "non-dependent silent spaces" (NSS)

时间窗: measurement of DSS and NSS are carried out prior to induction of anesthesia, 10 minutes after induction, 30 minutes after after installation of capnoperitoneum, 10 minutes after skin closure, 15 minutes after arrival at the PACU

The change of silent spaces under different ventilator settings during surgery is investigated.

次要结局

  • Oxygenation index(prior to induction of anesthesia, 10 minutes after induction, 30 minutes after installation of capnoperitoneum, 10 minutes after skin closure, 15 minutes after arrival at the PACU)
  • complinace of the respiratory system(10 minutes after induction, 30 minutes after capnoperitoneum applied, 10 minutes after skin closure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验