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Side Effects of Transesophageal Echocardiography

Primary Purpose

Upper Gastrointestinal Bleeding

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
endoscopy
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Upper Gastrointestinal Bleeding focused on measuring endoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Planned cardiac surgery
  • Age above 18 years
  • Signed informed consent
  • Clinical need for intraoperative use of transesophageal echocardiography

Exclusion Criteria:

  • Recent gastrointestinal pathologies (3-6 months)
  • Recent operations of the upper gastrointestinal tract (3-6 months)
  • Subjects not able to understand study procedures
  • No signed informed consent
  • Contraindications for transesophageal echocardiography
  • Antibiotic treatment within three months prior to surgery

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

endoscopy

Arm Description

endoscopy of the upper GI tract

Outcomes

Primary Outcome Measures

incidence of endoscopic mild mucosal injury
erythema, edema, hematoma, mucosal erosion, petechiae, or perforation of the upper GI mucosa

Secondary Outcome Measures

length of examination
Duration of the actual TEE examination
incidence of postoperative complications
GI bleeding, Perforation, swallowing difficulties

Full Information

First Posted
February 1, 2018
Last Updated
February 7, 2018
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT03432559
Brief Title
Side Effects of Transesophageal Echocardiography
Official Title
Local Side Effects of Transesophageal Echocardiography
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2009 (Actual)
Primary Completion Date
March 31, 2010 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Transesophageal echocardiography is commonly used during cardiac surgery. Complications of transesophageal echocardiography are rare (1,2%), but are often underestimated and can lead to unrecognized blood loss and site of infection. This study wants to assess the mucosa of pharynx, upper larynx, esophagus and stomach prior to and after echo probe insertion during cardiac surgery with endoscopy.
Detailed Description
Transesophageal echocardiography is commonly used during cardiac surgery. Main reasons for its use are the evaluation of cardiac function and valve morphology previous to and after cardiac surgery. Complications of transesophageal echocardiography are rare (1,2%). Described complications may involve the gastrointestinal, cardiovascular or respiratory system. The major complication of transesophageal echocardiography is local injury of the GI tract. Only massive bleeding and perforation were reported, minor injuries are not noticed in the early postoperative period but may play an important role, especially in patients discomfort, source of minor unrecognized blood loss and site of infection. As oropharyngeal bacteria are known to cause endocarditis and graft infection, this site of infection may be of special interest in cardiac surgery. Study objectives: To assess the mucosa of pharynx, upper larynx, esophagus and stomach prior to and after TEE probe insertion during cardiac surgery using flexible endoscopy. Design: Open, not randomized, observer blinded, pilot study. Inclusion criteria Planned cardiac surgery Age above 18 years Signed informed consent Clinical need for intraoperative use of transesophageal echocardiography Exclusion criteria Recent gastrointestinal pathologies (3-6 months) Recent operations of the upper gastrointestinal tract (3-6 months) Subjects not able to understand study procedures No signed informed consent Contraindications for transesophageal echocardiography After induction of anesthesia and insertion of all needed catheters (arterial catheter, central venous catheter, bladder catheter, and pulmonary artery catheter, if indicated) an expert physician will perform the endoscopy (Olympus; Hamburg, Germany) of pharynx, esophagus, and stomach in order to exclude (respectively map) any alteration of the mucosa. Immediately after endoscopy the transesophageal probe (6T, 6T-RS, 6Tc, 6Tc-RS Vivid GE; USA; X7-2T, S7-2omni, Philips), covered with a special condom, will be inserted. The TOE probe will remain 7-8 hours in the GI tract. Two standard echocardiographic examinations are routinely performed during cardiac operation; the first (prior to skin incision) is assigned as baseline evaluation of cardiac morphology and function; the second (after weaning from cardiopulmonary bypass) is performed to check the result of the surgical procedure respectively to determine cardiac function for decision-making of medical treatment. A routine TEE - examination follows guidelines for standard TEE views and examination workflow and includes a minimum of 11 views up to a maximum of 28 views, depending on the type of pathology. Average time needed to perform a standard TEE examination varies from 5-15minutes. For these reasons the number of TEE views per examination, the length of each examination, and the different probe positions (upper esophageal, mid esophageal, transgastric and deep transgastric) during examination and the length of stay of the probe in each position will be reported. As soon as the TEE probe has been removed the second endoscopy it will be performed in the same order as the baseline endoscopy. Possible lesions of the mucosa will be classified as described by Geene et al. (Greene 1999, #9) as follows: erythema, edema, hematoma, mucosal erosion, petechiae, and perforation. In particular pharynx, upper esophagus, mid esophagus, cardia, gastric fundus, und gastric body will be examined. The analysis of filmed examination will be performed by the endoscopist in a second time off-line, in a blind manner.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gastrointestinal Bleeding
Keywords
endoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
endoscopy of pharynx, upper esophagus, mid esophagus, cardia, gastric fundus, and gastric body
Masking
None (Open Label)
Masking Description
the investigator doing the transesophageal examination will not be informed about the results of the endoscopy
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
endoscopy
Arm Type
Other
Arm Description
endoscopy of the upper GI tract
Intervention Type
Diagnostic Test
Intervention Name(s)
endoscopy
Intervention Description
endoscopy of pharynx, upper esophagus, mid esophagus, cardia, gastric fundus, und gastric body
Primary Outcome Measure Information:
Title
incidence of endoscopic mild mucosal injury
Description
erythema, edema, hematoma, mucosal erosion, petechiae, or perforation of the upper GI mucosa
Time Frame
7-8 hours
Secondary Outcome Measure Information:
Title
length of examination
Description
Duration of the actual TEE examination
Time Frame
1 day
Title
incidence of postoperative complications
Description
GI bleeding, Perforation, swallowing difficulties
Time Frame
up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Planned cardiac surgery Age above 18 years Signed informed consent Clinical need for intraoperative use of transesophageal echocardiography Exclusion Criteria: Recent gastrointestinal pathologies (3-6 months) Recent operations of the upper gastrointestinal tract (3-6 months) Subjects not able to understand study procedures No signed informed consent Contraindications for transesophageal echocardiography Antibiotic treatment within three months prior to surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Weber, M.D.Ph.D.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

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Side Effects of Transesophageal Echocardiography

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