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临床试验/NCT02829242
NCT02829242终止不适用

Near Infrared Spectroscopy for Determination of Tissue Oxygenation in Patients Undergoing Robotic Assisted Laparoscopic Surgery in the Trendelenburg Position - A Feasibility Study

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
16
试验地点
1
主要终点
Tissue oxygenation in the lower limbs during surgery in the Trendelenburg position.

研究概览

简要总结

Some robotic endoscopic surgeries require a steep Trendelenburg position and a carbon dioxide pneumoperitoneum. This minimally invasive approach has the advantages of less postoperative pain, shorter hospital stay and faster recovery. After prolonged operative time in a Trendelenburg position rare but significant complications are a cerebral oedema or a well leg compartment syndrome.

Well leg compartment syndrome results from inadequate perfusion in the lower limbs and the perfusion pressure is decreased proportionally to the lower extremity elevation. The condition can lead to release of intracellular proteins and myoglobinuria, hyperpotassaemia and metabolic acidosis followed by cell necrosis. The risk for tissue damage increases after 4 hours in a Trendelenburg position.

If not promptly diagnosed and treated, a compartment syndrome has devastating complications like permanent dysfunction, limb loss, renal failure or even death.

There are no specific guidelines for diagnosis and for the timing of surgical decompression. Fasciotomy is a clinical decision. There is no universal agreement at which compartment pressure irreversible muscle damage occurs.

The only objective diagnostic tool available is currently to measure the intramuscular pressure, however this is invasive, painful and may yield unreliable results. An intracompartment pressure of 0- 10mm Hg is the normal range.

Near Infrared Spectroscopy (NIRS) monitors are validated and approved to measure cerebral and somatic tissue oxygenation below the sensors and may help detecting promptly a compartment syndrome.

Therefore, the investigators designed the present study to detect a change in the tissue oxygenation in the lower legs during robotic assisted, laparoscopic surgery in the Trendelenburg position.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients scheduled for robotic assisted laparoscopic surgery in a Trendelenburg position

排除标准

  • Preexisting moderate neurological disease
  • Moderate cerebrovascular disease
  • Coronary disease with angina pectoris (CCS ≥ 1)
  • Peripheral arterial disease II (with intermittent claudicatio)
  • Cardiac insufficiency (NYHA >2)
  • Tumour in pharynx, larynx or oesophagus, an aneurysm of the thoracic aorta

结局指标

主要结局

Tissue oxygenation in the lower limbs during surgery in the Trendelenburg position.

时间窗: during the operation

Change over time in tissue oxygenation in the lower limbs during surgery in the Trendelenburg position.

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

Barbara Kabon

MD

Medical University of Vienna

研究点 (1)

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