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临床试验/NCT06900426
NCT06900426已完成不适用

Lung Atelectasis Improvement Through Positive End Expiratory Pressure During Anesthetic Induction: a Randomized Trial

Fudan University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月28日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
the dorsal △EELV after 2 minutes anesthetic induction

研究概览

简要总结

Anesthetic induction could lead to lung atelectasis, increase intrapulmonary shunt, and potentially impair oxygenation. The study aimed to validate that a positive end-expiratory pressure (PEEP) of 10 cmH2O could reduce lung atelectasis, comparing to 0 or 5 cmH2O with limited overdistension.

详细描述

General anesthesia may introduce lung atelectasis, which causes an increase in intrapulmonary shunt, and impairs oxygenation, even in the lung-healthy subjects. The magnitude of shunt is correlated with the formation of pulmonary atelectasis. The study aimed to validate that a positive end-expiratory pressure (PEEP) of 10 cmH2O could reduce lung atelectasis, comparing to 0 or 5 cmH2O with limited overdistension. Surgical patients with healthy lungs were randomly assigned to receive 0, 5 or 10 cmH2O PEEP (PEEP0, PEEP5 and PEEP10 groups). Anesthetic induction was performed by certified registered anesthesiologists, during which the patients were mechanically ventilated using the volume-controlled mode. Electrical impedance tomography (EIT) was used to dynamically assess the lung atelectasis during anesthetic induction (spontaneous, mask, and endotracheal intubation ventilation). The primary outcome was the dorsal change of end expiratory lung impedance (△EELI) after 2 mins anesthetic induction. The secondary outcome was driving pressure, EIT-derived ventilation homogeneity, hemodynamics and PaO2/FiO2.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

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

  • between 18 and 80 years
  • scheduled for elective non-cardiothoracic cancer surgery
  • general anesthesia.

排除标准

  • acute or chronic respiratory disorders, such as chronic obstructive pulmonary disease (COPD) or asthma;
  • a history of lung surgery
  • a high risk of reflux and aspiration
  • a requirement for awake intubation
  • facial or thoracic deformities
  • the presence of implants, such as cardiac pacemakers

结局指标

主要结局

the dorsal △EELV after 2 minutes anesthetic induction

时间窗: 2 minutes after anesthetic induction

The primary outcome was the dorsal △EELV after 2 minutes anesthetic induction (endotracheal intubation ventilation) monitored by EIT.

次要结局

  • driving pressure(2 minutes after anesthetic induction)
  • GI(2 minutes after anesthetic induction)
  • CoV(2 minutes after anesthetic induction)
  • hemodynamics(During anesthetic induction)
  • PaO2/FiO2(During anesthetic induction)

研究者

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

Jun Zhang

Professor

Fudan University

研究点 (1)

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