Echo Detection of Endoscopic Retrograde Cholangiopancreatography (ERCP) Air Embolus

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
Nicholas Markin, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01535248
First received: August 8, 2011
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

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 Intervention
Air Embolism as A Complication of Medical Care
Other: Transthoracic Echocardiography

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Incidence of ERCP associated air embolism [ Time Frame: Participation will be for one day, during the time of the ERCP ] [ Designated as safety issue: Yes ]
    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:
  • Risk Factors associated with ERCP air embolus [ Time Frame: Participation will be for one day, during the time of the ERCP ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535248

Locations
United States, Nebraska
The Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Nicholas W Markin, MD    402-559-4081    nmarkin@unmc.edu   
Contact: Candice R Montzingo, MD, FASE    402.559.4081    cmontzin@unmc.edu   
Principal Investigator: Nicholas W Markin, MD         
Sub-Investigator: Candice R Montzingo, MD, FASE         
Sub-Investigator: Grant F Hutchins, MD         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Nicholas W Markin, MD University of Nebraska
  More Information

No publications provided

Responsible Party: Nicholas Markin, Chief Resident, Department of Anesthesiology, University of Nebraska
ClinicalTrials.gov Identifier: NCT01535248     History of Changes
Other Study ID Numbers: 238-11-FB
Study First Received: August 8, 2011
Last Updated: March 13, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014