Fluid Overload and Pulmonary Function After Coloesophagoplasty in Children. Single-central Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- duration of intensive care unit (ICU) stay
研究概览
简要总结
Esophageal atresia is a rare but severe malformation, and it requires early surgery. Coloesophagoplasty is surgical repair of the esophageal with an isoperistaltic transverse colon graft. In the postoperative period after coloesophagoplasty children require careful monitoring of fluid balance, because clinically significant fluid overload can lead to dysfunction of various organs and systems.
详细描述
Esophageal atresia (EA) is a defect of the embryogenesis of the laryngotracheal tube. There are isolated forms of EA and combinations with a tracheoesophageal fistula (TPF). Esophageal plastic surgery with an isoperistaltic transplant from the transverse colon was performed in children with EA. After this surgical intervention children require observation in the intensive care unit (ICU). During this period, infusion therapy satisfies physiological needs and compensates for physiological and pathological losses. However, it is not always possible to compensate for the body's fluid needs and maintain a normovolemic state. Thus, fluid overload develops. It is based on a pathophysiological process when severe operational stress leads to the damage of glycocalyx in the vascular wall. As a result, albumin freely passes into the interstitium, and oncotic pressure rises in tissues. Fluid overload in the intra- and postoperative period can be a factor in an unfavorable outcome, leading to organ damage, as well as death.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Month 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Аge from 1 month to 3 years
- •EA with / without
- •Tracheoesophageal fistula (TPF)
- •Сoloesophagoplasty.
排除标准
- •Аesophageal burn,
- •Oesophageal peptic stenosis,
- •Congenital heart disease
- •Cardiotonic support in the postoperative period
- •Renal malformations
- •Bacterial pneumonia in the postoperative period,
- •Bronchopulmonary malformations.
结局指标
主要结局
duration of intensive care unit (ICU) stay
时间窗: up to 30 days after the surgery
number of days in ICU after surgery before discharge
intraoperative fluid overload (IVF)
时间窗: during the surgery
((injected fluid (ml) - diuresis (ml) - blood loss (ml))/weight before surgery)\*100%
Fraction of Inspired Oxygen (FiO2)
时间窗: in the third postoperative day
Fraction of Inspired Oxygen (FiO2)
duration of ICU stay corrected to sedation
时间窗: up to 30 days after the surgery
duration of ICU stay corrected for the duration of sedation
duration of mechanical ventilation (MV)
时间窗: up to 30 days after the surgery
number of days of MV after surgery before switching to continuous positive airway pressure (CPAP)
fluid overload (FO) on the first postoperative day in the ICU
时间窗: during the first postoperative day, exclude intraoperative period
((injected fluid (ml)-lost fluid (ml))/weight before admission to ICU)\*100%
partial pressure of carbon dioxide (pC02)
时间窗: in the third postoperative day
partial pressure of carbon dioxide (pC02)
total fluid overload on the first postoperative day
时间窗: during the first postoperative day, include intraoperative period
((injected fluid (ml) - lost fluid (ml))/weight before surgery)\*100%
Oxygen saturation (Sp02)
时间窗: in the third postoperative day
Oxygen saturation (Sp02)
inspiratory pressure (Pin)
时间窗: in the third postoperative day
inspiratory pressure (Pin)
Positive end-expiratory pressure (PEEP)
时间窗: in the third postoperative day
Positive end-expiratory pressure (PEEP)
duration of MV corrected to sedation
时间窗: up to 30 days after the surgery
duration of MV corrected for the duration of sedation
Venous oxygen saturation (Svo2)
时间窗: in the third postoperative day
Venous oxygen saturation (Svo2)
次要结局
未报告次要终点