Echo Detection of Endoscopic Retrograde Cholangiopancreatography (ERCP) Air Embolus

NCT01535248 | Completed

• 1 other identifier: 0238-11-FB
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Air Embolism as A Complication of Medical Care

Keywords

ERCP; Transthoracic Echocardiography; Air Embolus; ERCP associated air embolus

Outcome Measures

Primary Outcomes (1)

• Incidence of ERCP associated air embolism

  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.

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

Secondary Outcomes (1)

• Risk Factors associated with ERCP air embolus

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

Study Arms (1)

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

Interventions

Transthoracic Echocardiography OTHER

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.

Also known as: Monitoring

All ERCP Patients

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Embolism, Air

Condition Hierarchy (Ancestors)

Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nicholas W Markin, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: February 17, 2012
• Study Start: March 7, 2012
• Primary Completion: December 30, 2015
• Study Completion: December 30, 2015
• Last Updated: September 6, 2023

Record last verified: 2023-08

Locations

US (1)