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临床试验/NCT03399123
NCT03399123Unknown不适用

Effect of Low Tidal Volume on Blood Loss During Laparoscopic Hepatectomy

Southwest Hospital, China1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
104
试验地点
1
主要终点
Blood loss

研究概览

简要总结

To explore the effect of low tidal volume on blood loss and gas exchange during laparoscopic hepatectomy

详细描述

Background & Aims:Liver cancer is an disease that threatening human health .Laparoscopic hepatectomy is more and more widely used.It is very important to reduce the bleeding during laparoscopic hepatectomy.The investigators found that low tidal volume can effectively reduce intraoperative bleeding.The aim of this study was to explore the effect of low tidal volume on blood loss and gas exchange during laparoscopic hepatectomy

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged from 18 to 70 years old;
  • •American association of anesthesiologists(ASA) score I to III;
  • •Ability to adhere to the study schedule;
  • •Ability to provide informed consent and complete all study assessments;
  • •Patients undergoing selective surgery of laparoscopic hepatectomy.

排除标准

  • •The New York Heart Association classification(NYHA) III to IV;
  • •Chronic obstructive pulmonary disease,respiratory failure, patients after thoracic surgery.
  • •BMI>32Kg/m2;
  • •Abnormal in blood coagulation function;
  • •Patients with mental disease;
  • •Patients with neuromuscular disease;
  • •Concurrent enrollment in another Randomized controlled trial(RCT);
  • •Absence of written informed consent.

研究组 & 干预措施

Low tidal volume group

Experimental

Use a low tidal volume(6'8ml/kg) ventilation mode during liver segmentation。

干预措施: Tidal volume (Other)

Standard tidal volume group

Active Comparator

Use a standard tidal volume(10'12ml/kg) ventilation mode during operation.

干预措施: Tidal volume (Other)

结局指标

主要结局

Blood loss

时间窗: through study completion, an average of 48hours

Blood loss during operation.

次要结局

  • mean arterial pressure(During operation)
  • oxygenation index(During operation)
  • central venous pressure(During operation)

研究者

发起方
Southwest Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shuguo Zheng, MD

Professor of Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China

Southwest Hospital, China

研究点 (1)

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