Side Effects of Transesophageal Echocardiography

NCT03432559 | Completed

• 1 other identifier: 164/2009
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Gastrointestinal Bleeding

Keywords

endoscopy

Outcome Measures

Primary Outcomes (1)

• incidence of endoscopic mild mucosal injury

  erythema, edema, hematoma, mucosal erosion, petechiae, or perforation of the upper GI mucosa

  7-8 hours

Secondary Outcomes (2)

• length of examination

  1 day

• incidence of postoperative complications

  up to 1 week

Study Arms (1)

endoscopy

OTHER

endoscopy of the upper GI tract

Diagnostic Test: endoscopy

Interventions

endoscopy DIAGNOSTIC_TEST

endoscopy of pharynx, upper esophagus, mid esophagus, cardia, gastric fundus, und gastric body

endoscopy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ulrike Weber, M.D.Ph.D.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: the investigator doing the transesophageal examination will not be informed about the results of the endoscopy
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Prof.Dr.

Model Details: endoscopy of pharynx, upper esophagus, mid esophagus, cardia, gastric fundus, and gastric body

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 14, 2018
• Study Start: July 1, 2009
• Primary Completion: March 31, 2010
• Study Completion: January 31, 2018
• Last Updated: February 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)