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Upper Gastrointestinal BleedingNCT03432559

Side Effects of Transesophageal Echocardiography

A study testing endoscopy in people with Upper Gastrointestinal Bleeding, run by Medical University of Vienna at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Upper Gastrointestinal Bleeding
What is being tested?
endoscopy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteAustria
Study dates
1 Jul 2009to 31 Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Austria1 site
  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

About this study

Official title: Local Side Effects of Transesophageal Echocardiography

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.

Read the 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.

Being tested
endoscopy
Keywords
endoscopy
Medical subject headings
Gastrointestinal Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endoscopyDiagnostic test

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

Study groups in NCT03432559
Study groupRoleWhat they receive
endoscopyOtherendoscopy of the upper GI tract
Receives: Diagnostic Test: endoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of endoscopic mild mucosal injury

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

    Measured: 7-8 hours

Secondary outcomes (2)
  1. length of examination

    Duration of the actual TEE examination

    Measured: 1 day

  2. incidence of postoperative complications

    GI bleeding, Perforation, swallowing difficulties

    Measured: up to 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2018
  2. Study start1 Jul 2009
  3. Primary completion31 Mar 2010
  4. Study completion31 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
endoscopy of pharynx, upper esophagus, mid esophagus, cardia, gastric fundus, and gastric body
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03432559
Sponsor's protocol ID
164/2009
Status last verified
Feb 2018
First submitted
1 Feb 2018
Last updated
14 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing endoscopy in people with Upper Gastrointestinal Bleeding, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of endoscopic mild mucosal injury (time frame: 7-8 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.

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