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临床试验/NCT07306845
NCT07306845尚未招募不适用

Veno-arterial CO2 Pressure Difference to Arterio-venous O2 Difference Ratio & Blood Lactate Levels Are Predictors of Postoperative Outcome in Whipple Procedures

Alexandria University0 个研究点目标入组 120 人开始时间: 2025年12月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Venous-to-Arterial CO₂ Gap (Pv-aCO₂ = PvCO₂ - PaCO₂)

研究概览

简要总结

Whipple surgery is a complex abdominal procedure associated with a high risk of hemodynamic instability and splanchnic hypoperfusion leading to anastomotic leaks, delayed gastric emptying, and organ dysfunction Traditional markers (e.g., MAP, mixed venous oxygen saturation [SvO₂], lactate) are indirect, invasive and often delayed.

CO₂-derived variables (e.g., venous-to-arterial CO₂ gap [ΔCO₂], tissue CO₂ [PtCO₂], end-tidal CO₂ [EtCO₂] changes) provide earlier and more sensitive signs of microcirculatory dysfunction.

详细描述

Whipple surgery is a complex abdominal procedure associated with a high risk of hemodynamic instability and splanchnic hypoperfusion leading to anastomotic leaks, delayed gastric emptying, and organ dysfunction Traditional markers (e.g., MAP, mixed venous oxygen saturation [SvO₂], lactate) are indirect, invasive and often delayed.

CO₂-derived variables (e.g., venous-to-arterial CO₂ gap [ΔCO₂], tissue CO₂ [PtCO₂], end-tidal CO₂ [EtCO₂] changes) provide earlier and more sensitive signs of microcirculatory dysfunction.

The present study investigate the hypothesis that simultaneous measurement of Venous-to-Arterial CO₂ Gap Indexed to Oxygen Content Difference (Pv-aCO₂/Ca-vO₂ Ratio & blood lactate may provide one or more early markers for post-operative adverse outcome in Whipple procedure

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • Adults (>18 years) undergoing open Whipple procedure under general anesthesia
  • Invasive monitoring (arterial line and central venous catheter)
  • Informed written consent

排除标准

  • Emergency surgery.
  • Preoperative septic shock or hemodynamic instability.
  • severe pre-existing **cardiopulmonary disease (e.g., severe COPD, heart failure).

结局指标

主要结局

Venous-to-Arterial CO₂ Gap (Pv-aCO₂ = PvCO₂ - PaCO₂)

时间窗: T0 baseline (After induction of anesthesia) T1 intraoperative (After major vessel dissection) T2 intraoperative (Immediately post-pancreatic resection) T3 intraoperative (After GIT anastomosis) T4 End of surgery T5 postoperative (2 hours)

Measured via arterial and central venous blood gases sampling throughout the Whipple procedure

Arterial-Venous oxygen content difference (Ca-vO₂ = CaO₂ - CvO₂)

时间窗: T0 baseline (After induction of anesthesia) T1 intraoperative (After major vessel dissection) T2 intraoperative (Immediately post-pancreatic resection) T3 intraoperative (After GIT anastomosis) T4 End of surgery T5 postoperative (2 hours) in ICU

Measured via arterial and central venous blood gases

Veno-arterial CO2 Pressure Difference to Arterio-venous O2 Difference Ratio (Pv-aCO₂/Ca-vO₂ ratio )

时间窗: T0 baseline (After induction of anesthesia) T1 intraoperative (After major vessel dissection) T2 intraoperative (Immediately post-pancreatic resection) T3 intraoperative (After GIT anastomosis) T4 End of surgery T5 postoperative (2 hours) in ICU

calculated by dividing the previous 2 measurements (Pv-aCO₂/Ca-vO₂ )

次要结局

  • ICU length of stay(postoperative 3 days)
  • Occurrence of post-operative complications(postoperatively within 1 month)
  • Traditional Perfusion Markers :Lactate(T0 baseline (After induction of anesthesia) T1 intraoperative (After major vessel dissection) T2 intraoperative (Immediately post-pancreatic resection) T3 intraoperative (After GIT anastomosis) T4 End of surgery T5 postoperative (2 hours) in ICU)
  • occurrence of Postoperative complications(within 3 days in ICU for complications, 30 days postoperatively for mortality)
  • occurrence of Organ dysfunction (AKI)(postoperatively within 3 days in ICU)
  • occurrence of postoperative complication as acute liver dysfunction(postoperatively within 3 days)

研究者

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

Alaa Anwar Aly Ahmed

LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE

Alexandria University

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