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临床试验/NCT01971996
NCT01971996已完成不适用

Measuring the Cerebral Oxygen Saturation With NIRS Sensor Placed on the Forehead of Patients in the Prone Position. How Does the External Pressure Affect the Measurement.

Glostrup University Hospital, Copenhagen1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Change in the regional cerebral oxygen saturation

研究概览

简要总结

During general anaesthesia, to ensure sufficient oxygen supply to the brain, the NIRS technology can be used. It consist of two sensors placed on the forehead, and measures the oxygen saturation of the tissue underneath the sensor. For patients undergoing back surgery placed in the prone position, the NIRS measurement will be affected, because the weight of the head will produce a pressure on the sensors. We wish to investigate how much the measurement is affected. Furthermore we plan to lift the head to remove the pressure, and record the time needed for the measurements to return to baseline.

详细描述

When placed in the prone position an external pressure is applied to the NIRS sensor. This pressure changes the amount of blood in the underlying tissue and thereby has an influence on the regional cerebral oxygen saturation measured. We wish to investigate to which extend this value is affected by the external pressure. Furthermore by lifting the head we want to investigate how long takes for the measurements to return to baseline (no pressure in the supine position).

Patients will receive written and oral information about the study, when seen by an anaesthesiologist prior to surgery. Before the anaesthesia one NIRS sensors is placed on the right side of the forehead, avoiding til frontal sinus, and one NIRA sensor is placed on the left musculus deltoideus. The patient is placed in the prone position with the head in af prone-view face mask. Measurements will start after 30 minutes with no change in infusion rate of anaesthetic and no inotropics administered. Registration of NIRS measurements will be done every 15 seconds, first five minutes without intervention, then five minutes with headlift, and last five minutes without interventions. Blood pressure, pulse, saturation, end-tidal carbon dioxide and temperature, will be recorded. Registration wil be om case report forms.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Surgery in the lumbar spine, in the prone position, with the head in a proneview facemask
  • Free and painless movement of the neck

排除标准

  • Known cervical spine pathology.

结局指标

主要结局

Change in the regional cerebral oxygen saturation

时间窗: 15 seconds

Measured by Near Infrared Spectroscopy

次要结局

  • The duration before the steady state in the regional cerebral oxygen saturation is obtained after changing the head position.(15 seconds)

研究者

发起方
Glostrup University Hospital, Copenhagen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Johnny Andersen

M.D.

Glostrup University Hospital, Copenhagen

研究点 (1)

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