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临床试验/NCT06166719
NCT06166719招募中不适用

Prediction of Complications After Major Gastrointestinal Surgery With Machine Learning and Point of Care Ultrasound: an Observational Cohort Study.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Post-operative complications

研究概览

简要总结

This is an observational study in patients undergoing major surgery. In which we attempt to predict complications (e.g. low blood pressure, ICU-admittance after major surgery using continuous blood pressure measurements. We will also attempt to predict their response to fluid therapy using point of care ultrasound. Eventually we aim to combine these methods to detect complications earlier and to give advice about whether or not administration of fluid is appropriate

详细描述

The primary aim of this study is to develop a machine learning framework to predict major complications after major gastro-intestinal surgery. Secondary aims include combining this framework with point of care ultrasound to determine the best initial resuscitative strategy; and to determine which ultrasound parameters are best predictive of fluid intolerance. Furthermore if the renin angiotensin aldosterone system is more active after liver resection.

Study design:

Single centre observational cohort study

Study population:

Adult patients undergoing elective major gastrointestinal surgery

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

  • ≥18 years of age.
  • elective major gastrointestinal surgery: esophagectomy, gastrectomy, pancreatomy or major liver resection (3 segments or more).

排除标准

  • no informed consent
  • Patients with major cardiac shunts
  • Patients with dialysis shunts or peritoneal dialysis
  • Patients in whom POCUS is not possible or assessment of fluid status is unreliable e.g. BMI> 40, pulmonary fibrosis.

结局指标

主要结局

Post-operative complications

时间窗: 28 days

mainly complications such as ICU admission, re-OR, hemodynamic or respiratory instability, death, organ failure

次要结局

  • fluid overload or fluid intolerance(28 days)

研究者

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

A.P.J. Vlaar

prof. dr.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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