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临床试验/NCT05138172
NCT05138172招募中不适用

Forced Air Heating to Prevent Hypothermia During Endoscopic Retrograde Cholangiography

Hannover Medical School2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
27
试验地点
2
主要终点
Highest absolute change of T from baseline at any time during intervention as well as at the end of intervention

研究概览

简要总结

The aim of this prospective observational study is to evaluate the role of a convective warming blanket to prevent hypothermia during sedation for an endoscopic retrograde cholangiography (ERC).

详细描述

During endoscopic retrograde cholangiography (ERC), deep medical sedation of the patient is routinely perform. Since ERC is a complex examination and in addition sometimes several intervention steps are necessary (bougienage, dilatation, brush cytology, specimen collection, insertion of plastic and metal stent prostheses), the sedation time is almost always > 30min, in many cases even up to one hour or longer. These patients are at risk for developing hypothermia (drop in core body temperature below 36 degrees Celsius).

It is well known from anesthesiologic research that even moderate perioperative hypothermia, however, can have potentially serious complications. These include increased mortality, cardiac complications such as arrhythmias and infarctions, coagulation disorders, and increased transfusion requirements and wound infections. Changes in serum concentrations of potassium and peripheral vasoconstriction with decrease in subcutaneous partial pressure of oxygen are also clinically important side effects of perioperative hypothermia.

However, the current 2014 German S3 guideline "Sedation in gastrointestinal endoscopy" does not mention peri- or intra-interventional temperature measurement or temperature management.

The aim of this prospective observational study is to evaluate the role of a convective warming blanket to prevent hypothermia during sedation for an ERC. From the description of various clinical endpoints, we seek to obtain sufficient evidence to support routine use of such a system in ERC examinations. This study has the potential to set the new standard for modern sedation during ERC interventions that recognizes the risk of hypothermia and identifies a strategy to avoid it.

For this purpose, we will use a device, that is already routinely used in all operation rooms in Germany, the so-called warm air device "Twinwarm, Generation III". This device has a valid CE mark and will be used according to its purpose "pre-, intra- and postoperative maintenance of the normothermic body temperature of the patient". The device will be used strictly in accordance with the existing in-house SOP "Heat Management" of 04/2021 of the Department of Anesthesiology and Intensive Care Medicine of Hannover Medical School (MHH).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

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

  • 未提供

排除标准

  • Patients < 18 years
  • Pregnant women

结局指标

主要结局

Highest absolute change of T from baseline at any time during intervention as well as at the end of intervention

时间窗: During Intervention

Primary Endpoint

次要结局

  • Hemodynamic stability(During Intervention)
  • Subjective Patient Satisfaction(6 hours after intervention)
  • Respiratory Stability(During Intervention)
  • Percentage of patients with a reduction of T below 36 degree Celsius at any time during intervention as well as at the end of intervention(During Intervention)
  • Percentage of patients with a reduction of T from baseline more than 1 degree Celsius at any time during intervention as well as at the end of intervention(During Intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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