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临床试验/NCT03942055
NCT03942055撤回不适用

Prospective Observational Study: The Association of B-7 Lung Ultrasound Pattern With the Development of Postoperative Pulmonary Edema After Major Non-cardiac Surgery

University of Alabama at Birmingham0 个研究点开始时间: 2018年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Incidence of Pulmonary Edema

研究概览

简要总结

The objective of this proposal is to conduct a randomized controlled study to examine the association between the increase in extravascular lung water as determined by lung ultrasound and the development of radiologic pulmonary edema as diagnosed by chest roentgenogram in patients undergoing major elective open intra-peritoneal surgeries under general endotracheal anesthesia.

详细描述

This study will be conducted at the University of Alabama at Birmingham's post- anesthesia care unit (PACU). A total of 60 patients will be randomly selected from the 5th and 7th floor surgical suite daily display boards and enrolled in the study. A preoperative and postoperative Point of Care (POCUS) lung U/S exam and Point of Care (POCUS) transthoracic echo will be performed with a Sonosite Edge II bedside U/S machine (approved by UAB Biomedical and Clinical Engineering Dept-#9365) in the pre-anesthesia holding area before the surgical procedure, and after the end of the procedure in the post- anesthesia care unit (PACU). EVLW will be defined as B-line score ≥7 before and after the surgical procedure. Pulmonary edema will be defined by the official radiology report on a chest X ray in the first 72 hrs postoperatively. Pre and Post Op POCUS Pulmonary Capillary Wedge Pressure (PCWP) will be obtained via Trans-thoracic bedside Ultrasound measuring Mitral Valve Inflow (E) Velocity and Early Diastolic Lateral Mitral Annulus Velocity/Tissue Doppler Imaging (E'). A 5-1Mhz Phased Array Probe will be used to obtain images. The PCWP data obtained will be used to correlate with EVLW findings. Ultrasound windows for PCWP measurements will be obtained using the Apical 4-chamber View and/or modified Subcostal View.-

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 ≥ 18 years of age, undergoing major elective intraperitoneal surgeries expected to be in hospital for 72 hours

排除标准

  • Patients < 18 years
  • Pregnant females
  • Cardiac EF 40% on last pre-operative echo
  • Prisoners

结局指标

主要结局

Incidence of Pulmonary Edema

时间窗: 72 hours after the surgical procedure

The development of newly onset pulmonary edema as diagnosed by chest X ray in the first 72 hrs post-operatively.

次要结局

未报告次要终点

研究者

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

Andrew Barker

Principal Investigator

University of Alabama at Birmingham

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