Echo Detection of Endoscopic Retrograde Cholangiopancreatography (ERCP) Air Embolus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01535248
Recruitment Status : Completed
First Posted : February 17, 2012
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):
Nicholas Markin, University of Nebraska

Brief Summary:
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.

Condition or disease Intervention/treatment
Air Embolism as A Complication of Medical Care Other: Transthoracic Echocardiography

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Echocardiographic Surveillance of Patients Undergoing Scheduled Endoscopic Retrograde Cholangiopancreatography for the Presence of Intracardiac Air Embolus
Study Start Date : March 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Group/Cohort Intervention/treatment
All ERCP Patients
All patients that will be approached for this study will be undergoing ERCP as part of their medical care.
Other: Transthoracic Echocardiography
Patients undergoing ERCP will have surveillance with transthoracic echocardiography with exams occurring every 10 mins or more often if needed to evaluate for the presence of intra-cardiac air associated with ERCP insufflation.
Other Name: Monitoring

Primary Outcome Measures :
  1. Incidence of ERCP associated air embolism [ Time Frame: 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.

Secondary Outcome Measures :
  1. Risk Factors associated with ERCP air embolus [ Time Frame: Participation will be for one day, during the time of the ERCP ]
    If it is found that there is a significant number of individuals that are found to have ERCP associated air embolus it would be a secondary goal to attempt to identify patient factors that might confer additional risk of air embolus to the patient.

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The Study Population will be all subjects who are scheduled to undergo ERCP and consent to participate in the protocol. No exclusions will be made based on gender or race to provide for a particular distribution, all subjects who would like to participate will be included.

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01535248

United States, Nebraska
The Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Principal Investigator: Nicholas W Markin, MD University of Nebraska

Responsible Party: Nicholas Markin, Assistant Professor, Department of Anesthesiology, University of Nebraska Identifier: NCT01535248     History of Changes
Other Study ID Numbers: 238-11-FB
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by Nicholas Markin, University of Nebraska:
Transthoracic Echocardiography
Air Embolus
ERCP associated air embolus

Additional relevant MeSH terms:
Embolism, Air
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases