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临床试验/NCT03619525
NCT03619525Unknown不适用

Bedside Lung Ultrasound to Assess Lung Recruiting Maneuver With Cardiopulmonary Bypass in Valvular Cardiac Surgery.

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
lung ultrasound score

研究概览

简要总结

The study is designed to use the lung ultrasound to assess the effect of intermittent lung recruitment during cardiopulmonary bypass in cardiac surgeries on extra vascular lung water.

详细描述

Significant respiratory dysfunction is a common problem after cardiac surgery, with an incidence of about 25%. the formation of atelectasis appears to be the primary factor responsible for increased intrapulmonary shunt after cardiac surgery with CPB. The investigators will use the lung ultrasound to evaluate the effects of intermittent recruitment of the lungs during CPB on extra vascular lung water (EVLW).

Objectives :

To evaluate the effect of intermittent lung recruitment during CPB in cardiac surgery on:

Lung ultrasound score (LUS),Oxygenation at different times postoperatively,Time for extubation and length of ICU stay

sixty patients aged from 18-60 years old, scheduled for elective cardiac surgery with CPB will be included in the study. Patients will be randomly allocated into one of two groups: Group A (n=30): will receive intermittent lung recruitment during CPB.Group B (n=30): control group.

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
Single (Investigator)

盲法说明

numbered, sealed opaque envelope.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged (18-60 years),
  • elective valvular cardiac surgery with cardiopulmonary bypass (CPB).

排除标准

  • • Emergency surgeries.
  • coronary artery bypass graft surgery
  • patients requiring re-exploration in the immediate postoperative period (within 2hours)
  • left Ventricular ejection fraction less than 40%
  • patients with preoperative congestive heart failure, cardiogenic shock , preoperative pulmonary edema
  • pre-existing severe chronic pulmonary dysfunction (defined as pulmonary disease requiring home oxygen therapy or causing shortness of breath after 1 to 2 flights of stairs)
  • Morbid obesity
  • Renally impaired patients with creatinine more than 2 mg/dl

研究组 & 干预措施

recruitment group

Active Comparator

will receive intermittent lung recruitment during CPB

干预措施: lung recruitment (Procedure)

control group

No Intervention

will recieve no intervention

结局指标

主要结局

lung ultrasound score

时间窗: Baseline,immediately at the end of operation. 2 hours after ICU admission

• The change of lung ultrasound score (a score ranging fom 0/36 to 36/36 where 0/36 is best while 36/36 is worst) from the baseline values for assessment of extra vascular lung water after CBP

次要结局

  • • The value of Doppler derived E/E' ratio.(Baseline,immediately at the end of operation. 2 hours after ICU admission)
  • • Oxygenation (po2),& (po2/fio2)(Baseline,immediately at the end of operation. 2 hours after ICU admission)
  • • Time for extubation(before extubation)
  • Length of ICU stay(before discharge to ward up to 1 week)

研究者

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

Maged Abdel-Wahab Abdel-Aziz

assistant lecturer

Cairo University

研究点 (2)

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