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临床试验/NCT02715310
NCT02715310Unknown不适用

Haemodynamic Monitoring in Head and Neck Cancer Patients

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Postoperative Complications

研究概览

简要总结

In order to estimate the effect of fluid management in regard to postoperative complications this observatory study will document every kind of fluid intervention peri- and intraoperatively.

详细描述

The extend of mass transfusions is known to correlate with postoperative complications. However, also crystalloid and colloidal infusions are under suspicion to cause postoperative complications. This study will capture any kind of fluid intervention perioperatively as well as intraoperatively. Intraoperative fluid management will be documented and matched with the operation steps respectively. The extend of fluid therapy will be correlated with general postoperative complications and especially with the survival of microvascular transplants.

For this purpose, there will be four questionaires. After informed consent, the first questionaire will cover the patient's history, risk factors and previous operations. The second questionaire will cover intraoperative fluid management, documented with the actual operation step. Furthermore, it will also intraoperative complications, cardiovascular-active medication. For closer monitoring, data from Picco will also be included. The third questionaire will be complete in the ICU covering similar content as the second questionaire. The last questionaire will cover the patient's progress on the general ward. Fluid management and tube feeding, as well as general postoperative complication and flap specific complications will be noted.

This study aims for 50-80 patients.

研究设计

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

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 old or older
  • admitted for head and neck surgery with microvascular transplantation due to head and neck tumors

排除标准

  • Pregnancy
  • missing informed consent
  • revisions and relapse operations
  • non tumor-associated operations
  • surgery without microvascular transplants

结局指标

主要结局

Postoperative Complications

时间窗: 1 week

General Complications e.g. affecting lung, cardiovascular system, kidneys

次要结局

  • Transplant Survival via Clinical Examination(One week)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (1)

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