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临床试验/NCT05345743
NCT05345743已完成不适用

The Incidence of Postoperative Pulmonary Complications in Patients With a Positive and Negative AIR-Test During General Anesthesia

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 632 人开始时间: 2022年4月21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
632
试验地点
1
主要终点
The incidence of postoperative pulmonary complications

研究概览

简要总结

The overall objective of this study is to describe the incidence of postoperative pulmonary complications in patients with a positive and negative AIR-test result. Second, the investigators wish to describe the incidence of a positive AIR-test and its association with the development of PPC. In addition, the investigators aim to describe whether mechanical ventilation strategy differs between patients with a positive and negative AIR-test.

详细描述

The 'AIR-test', a method wherein inspiratory oxygen concentration is reduced to 21% and pulse-oximetry hemoglobin saturation (SpO2) is monitored, can be used to demonstrate the presence of an atelectasis-induced alveolar shunt. It remains uncertain whether an intraoperative positive AIR-test is associated with clinical outcomes. It is hypothesized that in a general surgical population, the incidence of postoperative pulmonary complications (PPC) is higher in patients with a positive AIR-test than in patients with a negative AIR-test. The aim of this study is to describe the incidence of PPC in patients with a positive and in patients with a negative AIR-test. Second, the investigators want to describe the incidence of a positive AIR-test and its association with the development of PPC. The investigators also want to evaluate whether mechanical ventilation strategy differs between patients with a positive and negative AIR-test.

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 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing surgery under general anesthesia in the Amsterdam University Medical Centers, location Meibergdreef with an Endotracheal Tube;
  • Patients > 18 years;
  • Preoperative SpO2 of ≥97%;
  • AIR-test performed after induction of anesthesia, in a hemodynamic and respiratory steady state.

排除标准

  • Age < 18 years;
  • No consent/objection;
  • Patient participated in another conflicting interventional study on mechanical ventilation during general anesthesia

结局指标

主要结局

The incidence of postoperative pulmonary complications

时间窗: The first 5 postoperative days

Respiratory failure; Bronchospasm; Acute Respiratory Distress Syndrome (ARDS); Suspected pulmonary infection; Aspiration pneumonitis; Atelectasis; Pleural effusion; Pulmonary infiltrate; Cardiopulmonary effusion; Pneumothorax

次要结局

  • AIR-test result(Intraoperative period)
  • Tidal volume during general anesthesia for surgery(Intraoperative period)
  • Peak Pressure during general anesthesia for surgery(Intraoperative period)
  • Respiratory Rate during general anesthesia for surgery(Intraoperative period)
  • Fraction of Inspired Oxygen during general anesthesia for surgery(Intraoperative period)
  • Positive End-Expiratory Pressure during general anesthesia for surgery(Intraoperative period)
  • Driving Pressure during general anesthesia for surgery(Intraoperative period)
  • The incidence of the individual components of postoperative pulmonary complications(The first 5 postoperative days)
  • Length of hospital stay(From the day of surgery until the day of discharge, up to day 30)
  • Rate of all-cause mortality and in-hospital mortality(Postoperative day 5 and postoperative day 30)
  • End-tidal Carbon Dioxide (CO2) during general anesthesia for surgery(Intraoperative period)

研究者

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

Prof. Dr. Marcus J. Schultz

Prof. Dr.

Amsterdam UMC, location AMC

研究点 (1)

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