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.
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.
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.
- Conditions
- Upper Gastrointestinal Bleeding
- 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 group | Role | What they receive |
|---|---|---|
| endoscopy | Other | endoscopy 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.
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)
length of examination
Duration of the actual TEE examination
Measured: 1 day
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.
- First posted14 Feb 2018
- Study start1 Jul 2009
- Primary completion31 Mar 2010
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrike Weber, Medical University of Vienna
- Investigators
- Ulrike Weber, M.D.Ph.D., Principal investigator, Medical University of Vienna
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Side Effects of Transesophageal Echocardiography
- ClinicalTrials.gov ID
- NCT03432559
- Acronym / sponsor ID
- 164/2009
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jul 2009 (actual)
- Primary completion
- 31 Mar 2010 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- endoscopy of pharynx, upper esophagus, mid esophagus, cardia, gastric fundus, and gastric body
| Arm | Type | Receives |
|---|---|---|
| endoscopy | Other | Diagnostic Test: endoscopyendoscopy of the upper GI tract |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Planned cardiac surgery
- Age above 18 years
- Signed informed consent
- Clinical need for intraoperative use of transesophageal echocardiography
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopyendoscopy of pharynx, upper esophagus, mid esophagus, cardia, gastric fundus, und gastric body | Diagnostic test | endoscopy |
Primary outcome
incidence of endoscopic mild mucosal injury
Time frame: 7-8 hours
erythema, edema, hematoma, mucosal erosion, petechiae, or perforation of the upper GI mucosa
2 secondary outcomes
length of examination
Time frame: 1 day
incidence of postoperative complications
Time frame: up to 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrike Weber, M.D.Ph.D. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
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.