Intraoperative Volume Restriction in Esophageal Carcinoma Surgery: an Exploratory Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio)
研究概览
简要总结
An exploratory single-centre randomized clinical trial was performed in order to investigate whether the fluid volume administered during esophageal carcinoma surgery affects pulmonary gas exchange and tissue perfusion.
详细描述
A convenience sample of 16 patients admitted to the Department of Thoracic surgery University Hospital Centre Zagreb and scheduled for esophageal carcinoma surgery were enrolled prospectively in the study between June 2011 and August 2012.
Patients were randomly allocated into two groups, one of which received ≤ 8ml/kg/h of intraoperative fluid ("restrictive group") and another that received > 8 ml/kg/h of fluid ("liberal group").
Patients were excluded if they were younger than 18 years; if they had severe lung disease, chronic renal insufficiency, or a physical status classification > III on the American Society of Anesthesiologists (ASA) scale; or if it was impossible to perform epidural catheter placement or thoraco-phreno-laparotomy.
All patients underwent esophagectomy carried out according to the Lewis-Tanner approach.
Data on arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the ratio PaO2/FiO2 were collected 10 min after anesthesia was induced and again 6 h after surgery. Data on the metabolic markers creatinine and lactate were collected 10 min after anesthesia induction and 6 h after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •esophageal carcinoma
- •Lewis Tanner procedure (median laparotomy and right thoracotomy)
排除标准
- •younger than 18 years
- •severe lung disease
- •chronic renal insufficiency
- •a physical status classification > III on the American Society of Anesthesiologists (ASA) scale
- •impossible to perform epidural catheter placement
- •thoraco-phreno-laparotomy
结局指标
主要结局
Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio)
时间窗: 10 minutes, 6 hours
At the given time point, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the PaO2/FiO2 ratio will be measured. The results of Pa02/FiO2 ratio will be compared between two groups for each time point separately.
Creatinine Values During and After Esophageal Carcinoma Surgery
时间窗: 10 minutes, 6 hours
At the given time points, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, creatinine blood levels will be measured. The results will be compared between two groups for each time point separately.
Lactate Values During and After Esophageal Carcinoma Surgery
时间窗: 10 minutes, 6 hours
At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared between two groups for each time point separately.
Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management.
时间窗: 10 minutes, 6 hours
At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared inside the same group (liberal or restrictive).
次要结局
- Duration of Surgery(End of surgery.)
- Total Volume of Administered Intraoperative Fluid(End of surgery)
研究者
Maja Karaman Ilić
MD PhD
Klinički Bolnički Centar Zagreb