跳至主要内容
临床试验/NCT01535248
NCT01535248已完成不适用

Echocardiographic Surveillance of Patients Undergoing Scheduled Endoscopic Retrograde Cholangiopancreatography for the Presence of Intracardiac Air Embolus

University of Nebraska1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2012年3月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Incidence of ERCP associated air embolism

研究概览

简要总结

Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopy technique to visualize and evaluate the pancreatic and biliary systems. It has been reported that rare instances of air embolus have been found associated with the performance of an ERCP and many of these events are fatal. It is our proposal to use transthoracic echocardiography to continuously evaluate for the presence of intra-cardiac air secondary to ERCP venous air embolism and attempt to quantify the incidence of this complication and any potential patient factors that might increase the risk of this complication.

详细描述

Endoscopic Retrograde Cholangiopancreatography (ERCP) is commonly used in the diagnosis and treatment of biliary and pancreatic disease. There are case reports presented in the literature demonstrating adverse and often fatal events following air embolization associated with the performance of ERCP. The frequency of air embolus is extremely rare with the exact incidence unknown. In recent years the utilization of echocardiography to evaluate individuals with hemodynamic instability has led to the discovery of intracardiac air embolus seen in those individuals that demonstrated changes in either hemodynamic parameters or capnography values. There exists proposed mechanisms for the translocation of air from the foregut to the systemic venous circulation but not one of these mechanisms has yet been validated. Some proposed mechanisms include either through intrahepatic mechanisms where air crosses from the biliary tract to hepatic venules or potentially from the foregut into the portal vein and through shunt vessels into systemic venous circulation.

The exact frequency of air embolus is likely higher than the incidence of fatal or near-fatal complications reported in the literature. Individuals that had the best outcomes were usually intubated and had capnography to demonstrate a change suggestive of air embolus prior to significant hemodynamic changes.1 As this phenomenon has not previously been well described, it is possible that other patients suffer significant air embolus with myocardial or cerebral ischemic sequelae that were not recognized because echocardiography was not used as an early tool for evaluation of hemodynamically unstable patients. It is also possible that there are a number of patients that may suffer a venous air embolus from ERCP that is sub-clinical and therefore not causing enough change in cardiac function to alter either hemodynamic parameters or capnography values. The literature suggests that if a patient does not awake following ERCP, that imaging modalities, such as echocardiography be employed for evaluation.1 Understanding the frequency of this problem or which subgroups are at risk can further aid in the diagnosis and treatment of this complication.

Transthoracic echocardiography is a highly sensitive imaging modality and if adequate imaging windows can be obtained will demonstrate the presence of intracardiac air. The risk of performing the study on the patient is zero to very low. The potential risk of inaccurate interpretation should be avoided by the use of trained individuals in the acquisition and interpretation of transthoracic echocardiographic images.

The purpose of this study is to 1) identify individuals scheduled to undergo elective ERCP as part of their plan-of-care and perform transthoracic echocardiography for surveillance of intracardiac air embolus 2) record aspects of their past medical history that may potentially contribute to increased risk of systemic venous air embolus. This evaluation has not been presented in the literature and the primary end-point of this study would be to determine the frequency at which venous air embolus associated with ERCP occurs.

All individuals that meet inclusion criteria will be approached and consented in the pre-operative area prior to the planned procedure (ERCP). Their past medical history will be reviewed with the patient and special attention placed on particular co-morbid conditions that might be related to this phenomenon including but not limited to: portal hypertension, cirrhosis, portal vein thrombosis, and recent liver biopsy. The patient will then proceed to the procedure room as planned and while the patient is placed in the left lateral decubitus position and induced under anesthesia. An echocardiography-trained anesthesiologist will perform a transthoracic echocardiogram (TTE) concurrently while the gastroenterologist is performing the ERCP. We plan on conducting serial images at least every ten to fifteen minutes throughout the ERCP and more often as needed. At the conclusion of the procedure (ERCP) if there are no significant findings on TTE the patient will be returned to the supine position and taken to the recovery room. The written record of the TTE will then be entered into the study database within a separate research chart. In the event that the TTE shows the presence of intracardiac air embolus during the procedure the member of the study group performing the TTE will notify the endoscopist and anesthesia provider of the findings if the findings are significant enough to require a change in the patient's medical care. Reference to the algorithm will be made in each case and be available online if needed. Unless a moderate to severe embolic event occurs, the findings will not be communicated to the gastroenterologist so that he is blinded to the result maintained in the research chart. The purpose of this is to keep clinically insignificant emboli from being reported in the patient's medical record.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Subject is undergoing ERCP as part of their medical care
  • Subject will be of age 19 or older

排除标准

  • Subject positioning for the ERCP is prone, thereby inhibiting the performance of the TTE
  • Subject intolerance of the pressure of the TTE probe
  • Subject body habitus interferes with obtaining adequate images to assess for intra-cardiac air

结局指标

主要结局

Incidence of ERCP associated air embolism

时间窗: Participation will be for one day, during the time of the ERCP

Patients who are scheduled for ERCP as part of their routine care will be assessed for the presence of air embolus, both clinically relevant (in the form of hemodynamic changes) and those situations where air is identified and does not appear to have a clinical effect. This is scheduled to occur over one day's time and only during the procedure are we planning on performing the echo for surveillance of air emboli.

次要结局

  • Risk Factors associated with ERCP air embolus(Participation will be for one day, during the time of the ERCP)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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