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临床试验/NCT03467711
NCT03467711已完成不适用

The Use of Tidal Volume Challenge to Improve the Reliability of Dynamic Parameters (Pulse Pressure Variation and Stroke Volume Variation) During Pneumoperitoneum and Laparoscopic Surgery

Hallym University Kangnam Sacred Heart Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2018年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
PPV8

研究概览

简要总结

Laparoscopy is increasingly used for major abdominal and pelvic surgery. As this approach is also recommended in elderly patients with serious comorbidities, optimal fluid therapy guidance during this procedure is important.

Many studies have reported that less invasive dynamic indices such as pulse pressure variation (PPV) and stroke volume variation (SVV), which are derived from the arterial pressure waveform, are superior to static indices to predict fluid responsiveness. PPV and SVV are based on the heart-lung interaction and reflect cyclic changes in stroke volume induced by mechanical ventilation in the closed-chest condition. Therefore, their ability to predict fluid responsiveness can be affected by factors that influence the arterial tone or the compliance of the respiratory system.

Laparoscopic surgery for the abdominal visceral organs requires pneumoperitoneum and the Trendelenburg position to optimize surgical conditions, and can reduce cardiac output and respiratory compliance. Accordingly, the usefulness of PPV and SVV in predicting fluid responsiveness during laparoscopic surgery under these conditions may be questioned.

It has been clearly shown that the values of dynamic parameters are significantly correlated with the magnitude of VT. Min et al. reported that augmentation of PPV and SVV via a temporary increase in VT from 8 to 12 ml/kg improved their predictive power in the inconclusive zone with respect to fluid responsiveness (PPV values of 9% and 13%, respectively). Another recent study reported that on increasing VT from 6 to 8 ml/kg, augmented PPV and SVV, as well as their absolute changes, predicted fluid responsiveness with high sensitivity and specificity, even in critically ill patients receiving low VT.

Therefore, the aim of the current study was to investigate whether increasing VT from 6 to 8 ml/kg would improve the predictive power of PPV and SVV in patients undergoing robot-assisted laparoscopic surgery in the Trendelenburg position under lung-protective ventilation. We also assessed the ability of absolute changes in PPV and SVV values induced by a temporary increase in VT from 6 to 8 ml/kg to predict fluid responsiveness.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Adult patients who performed robot assisted laparoscopic surgery under Trendelenburg position

排除标准

  • preoperative arrhythmia
  • Severe bradycardia
  • Moderate to severe valvular disease
  • left ventricular ejection fraction < 50%
  • Poorly controlled hypertension (systolic BP > 160 mmHg)
  • Patients with renal insufficiency (creatinine > 1.5 mg/dL)
  • Moderate to severe liver disease
  • BMI >.30 or < 15 kg/ m2
  • preexisting pulmonary disease
  • FEV1 < 60% of predicted value
  • contraindications to oesophageal Doppler (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

PPV8

时间窗: 3min after tidal volume challenge

augmented pulse pressure variation using a temporary increase in VT

SVV8

时间窗: 3min after tidal volume challenge

augmented stroke volume variation using a temporary increase in VT

次要结局

  • SVV_fb(5min after fluid expansion)
  • PPV_fb(5min after fluid expansion)
  • ΔPPV6-8(3min after tidal volume challenge)
  • ΔSVV6-8(3min after tidal volume challenge)
  • PPV6(Before fluid expansion)
  • SVV6(Before fluid expansion)

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

Hallym University Kangnam Sacred Heart Hospital

研究点 (1)

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