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临床试验/NCT01680393
NCT01680393Unknown不适用

Stabilizing Cerebral and Circulatory Hemodynamics During Shoulder Surgery in the Beach Chair Position Using Sequential Compression Device (SCD) or TED Stockings Compared to a Control Group

Bispebjerg Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
cerebral oxygenation

研究概览

简要总结

This study is a 3-legged randomized study examining whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (SCD) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED stockings or a control group without any stockings.

详细描述

This study examines whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (SCD) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED stockings or a control group without any stockings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

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

入选标准

  • •adult patients undergoing elective shoulder surgery

排除标准

  • •untreated hypertension
  • •no pulse in a. dorsalis pedis or a.tibialis posterior
  • •leg ulcers
  • •failed scalenous blockade

研究组 & 干预措施

Sequential compression device

Experimental

During arthroscopic shoulder surgery, an SCD device will be applied to the patients legs during surgery. Cerebral oxygenation and circulatory parameters will be recorded continuously throughout the surgery. Recordings will be hidden to the primary caregiver.

干预措施: Sequential compression device (Device)

TED stockings

Experimental

During arthroscopic shoulder surgery, TED stockings will be applied to the patients legs during surgery. Cerebral oxygenation and circulatory parameters will be recorded continuously throughout the surgery. Recordings will be hidden to the primary caregiver.

干预措施: TED stockings (Other)

Control

No Intervention

no stockings will be applied to the patients legs

结局指标

主要结局

cerebral oxygenation

时间窗: per minute

cerebral oxygenation averaged of 1 min during the operation

次要结局

  • ephedrine(throughout duration of anaesthesia, approximately 60 minutes)
  • cardiac output(per minute)
  • Stroke volume(per minute)
  • mean arterial pressure(per minute)

研究者

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

Frank Christian Pott, MD

MD, DMSc

Bispebjerg Hospital

研究点 (1)

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