跳至主要内容
临床试验/NCT02653469
NCT02653469已完成不适用

Pulse Pressure Variation With Augmented Ventilation to Predict Fluid Responsiveness in the Patients Undergoing Open Laparotomy Surgery

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Augmented PPV (Pulse Pressure Variation) to predict fluid responsiveness

研究概览

简要总结

Pulse pressure variation (PPV) is a well-known and widely used dynamic preload indicator based on heart-lung interaction to predict fluid responsiveness. Generally, patients are considered to be fluid-responsive when the PPV value larger than 11-13%. However, several previous researches demonstrated that there is a zone of uncertainty (grey zone) in PPV. To predict fluid-responsiveness accurately in the patients with PPV within grey zone (9-13%), the investigators would evaluate the augmented PPV using augmented ventilation.

研究设计

研究类型
Observational
观察模型
Cohort
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 undergoing elective open laparotomy surgery.

排除标准

  • Irregular heart beats,
  • cardiac arrhythmia,
  • moderate or severe valvular heart disease,
  • preoperative left ventriular ejection fraction less than 40%,
  • moderate t severe obstructive pulmonary disease,
  • preoperative need of inotropics infusion,
  • preoperative serum Cr > 1.3ml/dl,
  • moderate to severe renal or liver disease,
  • acute lung injury or acute lung problem,
  • coexisting open chest condition,
  • severe bradycardia,
  • patients with spontaneous breathing

结局指标

主要结局

Augmented PPV (Pulse Pressure Variation) to predict fluid responsiveness

时间窗: within 2 min from augmented ventilation

Augmented ventilation (12ml/kg) will be performed when the participant's PPV is within grey zone (9-13%). PPV value will be collected automatically by Intelivue philips patient monitor. Percentage changes in stroke volume index by EV1000 according to fluid loading were used as principal indicators of fluid responsiveness. Patients were classified as responders or non-responders when increases in SVI were ≥ 10% or \<10% after volume loading (crystalloid iv 6ml/kg). To test the abilities of augmented PPV to predict fluid responsiveness, areas under the receiver operating characteristics (ROC) curves of the responders \[area under the curve (AUC) = 0.5: no better than chance, no prediction possible; AUC = 1.0: best possible prediction\] will be calculated.

次要结局

  • Conventional baseline PPV to predict fluid responsiveness(when patients PPV in grey zone, before augmented ventilation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jong Hwan Lee

Assistant professor

Samsung Medical Center

研究点 (1)

Loading locations...

相似试验