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临床试验/NCT06157138
NCT06157138招募中不适用

Incidence of B-Lines in Pulmonary Echography, in Patients Undergoing Open Abdominal Surgery.

Pontificia Universidad Catolica de Chile1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年12月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
62
试验地点
1
主要终点
Apparition of pulmonary B-Lines

研究概览

简要总结

There is no a reliable marker of intraoperative fluid excess or overload. The use of lung ultrasound in other settings, such as emergency room and critical care patients, helps us to determine if a patient has a condition of augmented intrathoracic fluid, that could be related to several circumstances, such as fluid overload, but also to heart failure, in example.

Nevertheless, there is no information regarding the basal incidence of this finding, to ascertain if could be eventually used as a potential marker of fluid overload. This protocol looks for the incidence of the finding of B-Lines, which are related to fluid overload, in patients undergoing open abdominal surgery.

详细描述

The presence of B-lines will be observed in 4 spaces at each evaluation: Anterior-superior, and infero-lateral, by each side.

The times of evaluation will be prior to intubation, after intubation, every one hour of surgery, at the end of the surgery prior to extubation, and after 2 hours in the postoperative care unit.

Other variables addressed will be the vital signs, parameters related to a diminished intravascular status (ie, pulse pressure variability), central venous pressure, volume changes (reposition, bleeding, diuresis), and requirements of blood products.

A correlation with baseline characteristics of patients will be observed; nevertheless, this study is directed as primary endpoint to evaluate the incidence of the B-lines in echography, and the sample size was calculated following this endpoint.

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

  • Patients scheduled to open abdominal surgery Older than 18 years.

排除标准

  • Previous thoracic surgery, BMI over 30 kg/m2 Baseline respiratory alterations related to preoperative supplementary oxygen requirements Evident malformations of the thoracic wall If the position required for the surgery does not allow the echographic windows required for the protocol

结局指标

主要结局

Apparition of pulmonary B-Lines

时间窗: During surgery and after 2 hours in the postoperative care unit

3 or more B-Lines in any evaluated quadrant

次要结局

  • Postoperative pulmonary complications(After 2 hours in the postoperative care unit)
  • fluid administration and B lines(During surgery)

研究者

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

Augusto Rolle

MD, MSc

Pontificia Universidad Catolica de Chile

研究点 (1)

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