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Role of Lung Ultrasound Imaging in the Comparison of Two Mechanical Ventilation Strategies During Laparotomy

Role of Lung Ultrasound Imaging in the Comparison of Two Mechanical Ventilation Strategies During Laparotomy.

The use of positive end-expiratory pressure (PEEP) and recruitment maneuvers during laparotomy will limit the development of atelectasis and therefore improve the aeration score.

研究概览

详细说明

Postoperative pulmonary complications contribute to the morbidity of surgical patients. During general anesthesia, up to 90% of patients will develop atelectasis, which is thought to be a major contributing factor to their development. The adjustment of ventilator settings to prevent the occurrence of atelectasis and reduce pulmonary complications remains controversial. Despite the use of similar mechanical ventilation strategies, two recent studies (IMPROVE, PROVHILO) involving 1300 patients diverged in their conclusions regarding the impact of these strategies in the prevention of pulmonary complications. In these studies, the absence of imagery to assess the pulmonary end-result of the different ventilation strategies complicates the interpretation of their results.

On arrival in the operating theatre, each patient will undergo a baseline lung ultrasound examination. The anesthetic technique and monitoring will be standardized. The radial artery will be cannulated after induction of anesthesia for blood gas monitoring. Ventilator settings will be adjusted according to randomization.

A second lung ultrasound examination will be performed 5 minutes following induction of general anesthesia. In the PEEP group, a lung ultrasound examination will be performed immediately following the first recruitment maneuver. A lung ultrasound examination will also be performed at the end of surgery before emergence of general anesthesia.

Fifteen minutes after arrival in the recovery room, a last lung ultrasound examination will be performed. Fraction of inspired oxygen (FiO2) and vital signs will be recorded during each ultrasound examination. Arterial blood samples will be collected simultaneously. The aeration score will be calculated for each lung ultrasound examination.

研究类型

介入性

注册 (实际的)

44

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Quebec
      • Montreal、Quebec、加拿大、H2L 4M1
        • Centre Hospitalier de l'Université de Montréal (CHUM)

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients aged 18 years and older
  • Scheduled for surgery by laparotomy (expected to last at least 2 hours)
  • American Society of Anesthesiologists classification: physical status 1-3

Exclusion Criteria:

  • Previous thoracic procedure (thoracic drain, thoracotomy, thoracoscopy)
  • Contraindication to the placement of an arterial line
  • Very severe chronic obstructive pulmonary disease

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:PEEP and recruitment maneuvers
A PEEP of 7 cm H2O will be applied starting after intubation until the end of surgery. Recruitment maneuvers (continuous positive pressure of 30 cm H20 for 30 seconds) will be initiated following intubation and repeated every 30 minutes during surgery and immediately prior to extubation. Lung ultrasound examinations will be performed at different time-points immediately before surgery, during surgery under general anesthesia and after surgery in the recovery room to detect and monitor atelectasis.
有源比较器:ZEEP (Zero end-expiratory pressure)
No PEEP nor recruitment maneuvers will be used during surgery. Lung ultrasound examinations will be performed at different time-points immediately before surgery, during surgery under general anesthesia and after surgery in the recovery room to detect and monitor atelectasis.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Lung aeration
大体时间:Post-induction to pre-emergence of anesthesia - Day 0
Compare lung aeration between two different mechanical ventilation strategies (with or without PEEP and recruitment maneuvers) using ultrasound imaging and a four point aeration score (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation).
Post-induction to pre-emergence of anesthesia - Day 0

次要结果测量

结果测量
措施说明
大体时间
Re-aeration following recruitment maneuvers
大体时间:Prior and after the first recruitment maneuver during general anesthesia - Day 0
Assess lung re-aeration following a recruitment maneuver by ultrasound imaging (lung aeration score pre/post the first recruitment maneuver during general anesthesia).
Prior and after the first recruitment maneuver during general anesthesia - Day 0
Atelectasis secondary to induction
大体时间:Lung aeration score prior and after intubation - Day 0
Estimate development of atelectasis secondary to intubation.
Lung aeration score prior and after intubation - Day 0
Atelectasis secondary to extubation
大体时间:Lung aeration score prior and after extubation - Day 0
Estimate development of atelectasis secondary to extubation.
Lung aeration score prior and after extubation - Day 0

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年2月1日

初级完成 (实际的)

2015年12月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2014年2月3日

首先提交符合 QC 标准的

2014年2月4日

首次发布 (估计)

2014年2月5日

研究记录更新

最后更新发布 (估计)

2016年1月26日

上次提交的符合 QC 标准的更新

2016年1月25日

最后验证

2016年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 13.293

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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