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临床试验/NCT04607993
NCT04607993已完成不适用

Study on the Effectiveness and Feasibility of Prone Position Ventilation Technique for Postoperative Acute Lung Injury in Infants With Congenital Heart Disease

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
Oxygenation index

研究概览

简要总结

The purpose of this study was to compare the effects of conventional lying position and prone position ventilation on infants with acute lung injury after surgery for congenital heart disease. To explore the effectiveness and feasibility of prone position ventilation for children with acute lung injury after congenital heart disease surgery.

详细描述

The prone position has been used to treat severe hypoxemia in patients with acute respiration dysfunction syndrome (ARDS) since the 1970s, and it has significant effectiveness in improving gas exchange. Acute lung injury (ALI) is a common complication after congenital heart disease. The clinical manifestation is refractory hypoxemia. At present, mechanical ventilation is one of the main methods for the treatment of acute lung injury-induced respiratory distress syndrome. Prone position ventilation refers to placing the patient in the prone position during mechanical ventilation to expand the lungs in the atelectasis area and improve the ratio of lung ventilation and perfusion.

Prone position ventilation technology as an important lung protection ventilation strategy has been widely used clinically at home and abroad. Compared with adults, children are more convenient and easy to implement. Due to the exact mechanism of improving oxygenation function, the current domestic and foreign development of pediatric prone ventilation technology is mainly focused on children with ARDS. There are few studies on high-quality application effects after pediatric cardiac surgery, and almost no research has been carried out, especially for pediatric heart The indications for the implementation of the prone position after the disease surgery, the specific standardized process including the position angle, the prone duration plan, etc. all need to be studied. Therefore, there is an urgent need to develop prone position ventilation technology for critically ill children with congenital heart disease after surgery to reduce postoperative pulmonary complications and shorten the time of mechanical ventilation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 1 Year(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with lung injury after congenital heart disease or chest X-ray CT suggest that pulmonary complications need to strengthen body drainage
  • •Establish artificial airway, such as tracheal intubation
  • •Children aged 0-12 months
  • •Stable hemodynamics, more than 72 hours after surgery
  • •Informed consent of family members

排除标准

  • •Unstable hemodynamics, severe hypotension, ventricular arrhythmia
  • •Intracranial hypertension
  • •Active acute bleeding
  • •Spinal injuries and untreated unstable fractures, orthopedic surgery or recent abdominal surgery
  • •Facial trauma
  • •Severe pneumothorax
  • •Delayed chest closure and wound infection, children who need to be immobilized

研究组 & 干预措施

Prone position ventilation technique

Experimental

Prone position ventilation for children with congenital heart disease after surgery

干预措施: Prone position ventilation technique (Behavioral)

Control group

No Intervention

conventional postoperative position, no prone position ventilation

结局指标

主要结局

Oxygenation index

时间窗: at 6th hours after enrollment

Oxygenation index refers to a goal in respiratory therapy,OI(mmHg)=PaO2/FiO2 It is a continuous variable.

次要结局

  • Lung compliance(at 6th hours after enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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