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临床试验/NCT05401526
NCT05401526已完成不适用

Ability of Challenge With 5 cmH2O of Positive End-expiratory Pressure to Predict Fluid Responsiveness in Prone Position: An Observational Study

Istanbul University1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2022年6月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
1
主要终点
Verification of stroke volume index percentage change after SLPC

研究概览

简要总结

We are planning to measure hemodynamic parameters (Heart Rate, Mean Arterial Pressure, Stroke Volume Index, Stroke Volume Variation, and Pulse Pressure Variation) and ventilatory parameters at four times (T1, T2,T3, and T4) during spinal operation at prone position. First measurement (T1, First baseline) will be performed in the prone position after performing tracheal intubation and confirming hemodynamic stability (defined as mean arterial pressure <10% for 3 minutes). After the T1 measurement, additional 5 cmH2O PEEP (Positive end-expiratory pressure) will be applied for 30 seconds which will be called as "short term low PEEP challenge (SLPC)". At the end of the SLPC and prior to PEEP lowering, T2 measurement will be performed and recorded. After the T2 measurement, PEEP will be decreased to the initial value (5 cmH2O) and three minutes later, a second baseline (T3) measurement will be performed. Thereafter, 500 ml isotonic saline will be loaded in 10 minutes. T4 measurement will be performed again three minutes after volume loading. All of the measurements will be completed before surgery start and surgical stimulus. Patients exhibiting an increase in stroke volume index more than 15% after fluid loading (between T3 and T4) will be classified as volume responders. Absolute pulse pressure variation change due to SLPC, Absolute Stroke volume variation change due to SLPC, stroke volume index percentage change due to SLPC, and stroke volume index percentage change after fluid loading will be calculated and compared. Our aim is to observe if short term low PEEP challenge has the ability to predict fluid responsiveness better than pulse pressure variation and stroke volume variation for patients operated in prone position.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing spine surgery in prone position
  • Age≥ 18 years
  • Elective surgery

排除标准

  • American Society of Anesthesiology physical status over III
  • Valvular heart disease
  • Any ventricular dysfunction
  • Preoperative arrythmias
  • Preoperative hemodynamic instability
  • Preoperative uncontrolled hypertension
  • Preoperative uncontrolled diabetes mellitus
  • History of lung disease
  • Morbid obesity (Body mass index ≥ 40 kg/m2)

结局指标

主要结局

Verification of stroke volume index percentage change after SLPC

时间窗: Up to 30 minutes

Stroke volume index percentage change after SLPC means " \[(SVIT2 - SVIT1) / SVIT1\] x 100".

Verification of stroke volume index percentage change after fluid loading

时间窗: Up to 30 minutes

Stroke volume variation and pulse pressure variation values will be measured at second baseline (T3) and after fluid loading (T4). Fluid responsive patients means " stroke volume index increase after fluid loading ≥ 15%". In another explanation; \[(SVIT4- SVIT3)/ SVI (T3)\]x100 ≥ 15% means fluid responsive patients.

Ability of fluid responsiveness prediction with SVV, PPV, and Stroke volume index percentage change after SLPC

时间窗: Up to 30 minutes

Predictive ability of SVI changes after SLPC and fluid loading will be compared by statistical analysis (ROC curve)

次要结局

未报告次要终点

研究者

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

Emre Sertaç Bingül

Medical Doctor, Lecturer

Istanbul University

研究点 (1)

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