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临床试验/NCT05187039
NCT05187039已完成不适用

Evaluation of Atelectasis Formation and Regression With Electrical Impedance Tomography in the Perioperative Phase of Obese Patients Scheduled for Laparoscopic Bariatric Surgery

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Proportion of poorly ventilated lung areas (silent spaces)

研究概览

简要总结

This study investigates under controlled conditions the variation of poorly ventilated lung units (silent spaces) in obese patients scheduled for laparoscopic bariatric surgery in the perioperative phase.

详细描述

Eligible patients with written informed consent, scheduled for laparoscopic bariatric surgery. As for standard of care no premedication will be given for bariatric patients. Patients will be monitored according the local standard.

Thoracic electrical impedance tomography measurements (each measurement will last 1 min) will be performed at the following time points: before induction of the anaesthesia; before the surgical procedure when the induction is terminated and recruitment manoeuvers have been performed; after the termination of the surgical procedure; before transport to the Post anaesthesia Care Unit (PACU); before the discharge from the PACU after 2 hours of monitoring. An additional thoracic electrical impedance tomography measurement (duration 1 min) will be performed before discharge at home. For this, resulting potential differences are measured, and impedance distribution sampled at 30 Hz will be calculated by an automated linearized Newton-Raphson reconstruction algorithm. Relative change in poorly ventilated lung regions (silent spaces) and end-expiratory lung impedance (EELI) and measures of ventilation inhomogeneity such as the global inhomogeneity index will be calculated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • ASA physical status 1 to 4
  • Over 18 years of age providing written informed consent

排除标准

  • Known severe pulmonary hypertension,
  • Need of home oxygen therapy
  • Known heart failure
  • Suspected, or known recent pulmonal infections

结局指标

主要结局

Proportion of poorly ventilated lung areas (silent spaces)

时间窗: 2 hours

Proportion of poorly ventilated lung areas (silent spaces) by using electrical impedance tomography (EIT) before the discharge from PACU (two hours after admission to PACU).

次要结局

  • Duration of anaesthesia(Up to 90 to 180 minutes)
  • EIT-Measurement after the end of induction before the surgical procedure(2 minutes after the end of anesthesia induction)
  • EIT-Measurement 2 minutes after the end of anaesthesia, before the transport in PACU(2 minutes after the end of anaesthesia, before the transport to PACU.)
  • EIT-Measurement at the end of the surgical procedure(5 minutes after Capnoperitoneum)
  • EIT-Measurement before discharge from the PACU(Two hours after admission of the patient at PACU, before first mobilisation and before discharge from PACU)
  • EIT-Measurement before discharging the patient at home(At hospital discharge, up to 3 days)
  • Duration of surgical procedure.(Up to 90 to 150 minutes)
  • Desaturation below 90%.(During anaesthesia monitoring, from 1 to 10 minutes)
  • Follow up at 14 days(14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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