跳至主要内容
临床试验/NCT02886546
NCT02886546终止不适用

Utility of Dynamic Variables Measured by Calibrated Pulse Contour Analysis of Oesophageal Doppler Monitor for Predicting Fluid Responsiveness During Robot-Assisted Laparoscopic Prostatectomy

Hallym University Kangnam Sacred Heart Hospital0 个研究点目标入组 26 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
26
主要终点
SVV (stroke volume variation)

研究概览

简要总结

Robot-assisted laparoscopic prostatectomy (RALP) is widely performed due to its many advantages, including a reduced need for blood transfusion and fewer surgical complications compared with conventional open prostatectomy. As this approach is also recommended in elderly patients with serious comorbidities, optimal fluid therapy guidance during this procedure is important.

Dynamic variables such as pulse pressure variation (PPV) and stroke volume variation (SVV) are used to predict and guide fluid therapy during controlled ventilation. These variables arise from heart-lung interactions during positive pressure ventilation, which influence left ventricular stroke volume (SV). RALP requires carbon dioxide insufflation and the steep Trendelenburg position to optimise surgical conditions, and can reduce cardiac output and respiratory compliance. Accordingly, the usefulness of PPV and SVV, which are affected by changes in intrathoracic pressure, in predicting fluid responsiveness during laparoscopic surgery under these conditions may be questioned. A recent study established that PPV and SVV derived by uncalibrated pulse contour analysis had a relatively poor capacity to predict fluid responsiveness during laparoscopy on dynamic preload indices. In contrast, another study SVV measured by oesophageal Doppler monitor (ODM) could predict fluid responsiveness during laparoscopic surgery.

The CardioQ-ODM+ combines the proven ODM Doppler measurement of blood flow with pulse contour analysis, which is quickly and easily calibrated from the Doppler signal. We hypothesized that PPV and SVV measured by calibrated pulse contour analysis would be a good indicator of fluid responsiveness during laparoscopy with pneumoperitoneum.

The primary objective of this study was to demonstrate that PPV and SVV measured by calibrated pulse contour analysis of CardioQ-ODM+ can accurately predict fluid responsiveness during RALP, which involves both pneumoperitoneum and the Trendelenburg position. Investigators also assessed the capacity of other dynamic variables (SPV [systolic pressure variation], and SVV determined by ODM Doppler flow, dynamic elastance [PPV/SVV] and corrected flow time [FTc]) to predict fluid responsiveness during RALP.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • patients undergoing elective robot-assisted laparoscopic prostatectomy

排除标准

  • patients with a BMI > 30 or , < 15 kg/m2 valvular heart disease left ventricular ejection fraction < 50% a history of lung disease preoperative arrhythmia contraindications to OED monitoring probe insertion (i.e. oesophageal stent, carcinoma of the oesophagus or pharynx, previous oesophageal surgery, oesophageal stricture, oesophageal varices, pharyngeal pouch, and severe coagulopathy)

结局指标

主要结局

SVV (stroke volume variation)

时间窗: Measurements were performed before and after volume expansion during pneumoperitoneum

measured by calibrated pulse contour analysis of CardioQ-ODM+

PPV (pulse pressure variation)

时间窗: Measurements were performed before and after volume expansion during pneumoperitoneum

measured by calibrated pulse contour analysis of CardioQ-ODM+

次要结局

  • Dynamic elastance(Measurements were performed before and after volume expansion during pneumoperitoneum)
  • FTc (corrected flow time)(Measurements were performed before and after volume expansion during pneumoperitoneum)
  • SPV (systolic pressure variation)(Measurements were performed before and after volume expansion during pneumoperitoneum)
  • SVV_flow(Measurements were performed before and after volume expansion during pneumoperitoneum)

研究者

发起方
Hallym University Kangnam Sacred Heart Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun joohyun

Assistant Professor, Department of Anesthesiology and Pain Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine

Hallym University Kangnam Sacred Heart Hospital

相似试验