TEE Image QualityNCT07209293
Oral Gastric Suctioning Effect on Transesophageal Echo
An observational study of TEE Image Quality, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
During heart surgery images of the heart are taken with transesophageal echocardiography. The images track how the heart is doing during surgery. It is normal practice to place an oral gastric tube in the stomach during heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TEE Image Quality
- What is being tested?
- Transesophageal Echocardiography
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2025to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients scheduled for cardiac surgery at Atrium Health Wake Forest Baptist
Who may be able to join
- Transesophageal echocardiography assisted cardiac surgery
Who cannot join
- hiatal hernia
- documented or suspected esophageal stricture
- contraindications to a TEE
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atrium Health-Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Scott R Coleman, DO, 336-716-4498, Scott.Coleman@advocatehealth.org
Lynnette C. Harris, BSN, 336-716-8791, lynnettte.harris@advocatehealth.org
About this study
Official title: The Effect of Orogastric Suctioning on Quality of Transesophageal Echo Images in Cardiac Surgery
During heart surgery images of the heart are taken with transesophageal echocardiography. The images track how the heart is doing during surgery. It is normal practice to place an oral gastric tube in the stomach during heart surgery. The oral gastric tube is used to suction out stomach contents to avoid potential aspiration and avoid stomach acid build up. The purpose of this research study is to see if the images of the heart have better quality after your stomach has been emptied. This project hopes to help determine the best method to obtain the better quality images of the heart during cardiac surgery.
Read the detailed description
After induction, the transesophageal echocardiography (TEE) probe will be placed in the usual fashion for the cardiac surgery case. Five specific images that are part of a standard TEE exam will be obtained by TEE. An oral gastric (OG) tube will then be placed to suction stomach contents. The OG tube will then be removed and the same five images previously taken will be repeated. The five images reviewed from the TEE include mid esophageal four chamber, mid esophageal two chamber, transgastric basal, transgastric mid-papillary and deep transgastric. Two blinded and independent cardiologists who are echocardiography experts will review the before and after images and grade them for quality of the images. They will grade the images on a scale of 1-4 with 1 being excellent quality and 4 being very poor quality.
- Conditions
- TEE Image Quality
- Being tested
- Transesophageal Echocardiography
- Keywords
- gastric suction, transesophageal echocardiography, cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal EchocardiographyDiagnostic test
Transesophageal echocardiography images will be taken prior to and post oral gastric suction.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Surgery with Transesophageal Echocardiography | Participants scheduled for cardiac surgery with transesophageal echocardiography performed as part of their standard of care treatment during their surgery. Receives: Diagnostic Test: Transesophageal Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Mid Esophageal Four Chamber Images - Pre Oral Gastric Suction
Using transesophageal echocardiography mid esophageal four chamber images will be taken prior to oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Measured: 60 minutes
Quality of Mid Esophageal Four Chamber Images - Post Oral Gastric Suction
Using transesophageal echocardiography mid esophageal four chamber images will be taken post oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Measured: 60 minutes
Quality of Transgastric Basal Images - Pre Oral Gastric Suction
Using transesophageal echocardiography transgastric basal images will be taken prior to oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Measured: 60 minutes
Quality of Transgastric Basal Images - Post Gastric Suction
Using transesophageal echocardiography transgastric basal images will be taken post oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Measured: 60 minutes
Quality of Transgastric Mid Papillary Images - Pre Oral Gastric Suction
Using transesophageal echocardiography transgastric mid images will be taken prior to oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Measured: 60 minutes
Quality of Transgastric Mid Papillary Images - Post Oral Gastric Suction
Using transesophageal echocardiography transgastric mid images will be taken post oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Measured: 60 minutes
Quality of Mid Esophageal Two-Chamber Images - Pre Oral Gastric Suction
Using transesophageal echocardiography mid esophageal two-chamber images will be taken prior to oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Measured: 60 minutes
Quality of Mid Esophageal Two-Chamber Images - Post Oral Gastric Suction
Using transesophageal echocardiography mid esophageal two-chamber images will be taken post oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Measured: 60 minutes
Quality of Deep Transgastric Images - Pre Oral Gastric Suction
Using transesophageal echocardiography deep transgastric images will be taken prior to oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Measured: 60 minutes
Quality of Deep Transgastric Images - Post Oral Gastric Suction
Using transesophageal echocardiography deep transgastric images will be taken post oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start22 Oct 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TEE Image QualityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Coleman, DO, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209293
- Sponsor's protocol ID
- IRB00137024
- Status last verified
- Aug 2026
- First submitted
- 30 Sep 2025
- Last updated
- 25 Aug 2026
- 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Orogastric Suctioning on Quality of Transesophageal Echo Images in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07209293
- Acronym / sponsor ID
- IRB00137024
- Conditions
- TEE Image Quality
- Keywords
- gastric suction, transesophageal echocardiography, cardiac surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 6 Oct 2025 (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.
During heart surgery images of the heart are taken with transesophageal echocardiography. The images track how the heart is doing during surgery. It is normal practice to place an oral gastric tube in the stomach during heart surgery. The oral gastric tube is used to suction out stomach contents to avoid potential aspiration and avoid stomach acid build up. The purpose of this research study is to see if the images of the heart have better quality after your stomach has been emptied. This project hopes to help determine the best method to obtain the better quality images of the heart during cardiac surgery.
Detailed description
After induction, the transesophageal echocardiography (TEE) probe will be placed in the usual fashion for the cardiac surgery case. Five specific images that are part of a standard TEE exam will be obtained by TEE. An oral gastric (OG) tube will then be placed to suction stomach contents. The OG tube will then be removed and the same five images previously taken will be repeated. The five images reviewed from the TEE include mid esophageal four chamber, mid esophageal two chamber, transgastric basal, transgastric mid-papillary and deep transgastric. Two blinded and independent cardiologists who are echocardiography experts will review the before and after images and grade them for quality of the images. They will grade the images on a scale of 1-4 with 1 being excellent quality and 4 being very poor quality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Surgery with Transesophageal Echocardiography | – | Diagnostic Test: Transesophageal EchocardiographyParticipants scheduled for cardiac surgery with transesophageal echocardiography performed as part of their standard of care treatment during their surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for cardiac surgery at Atrium Health Wake Forest Baptist
Key inclusion criteria (1 listed)
- Transesophageal echocardiography assisted cardiac surgery
Key exclusion criteria (3 listed)
- hiatal hernia
- documented or suspected esophageal stricture
- contraindications to a TEE
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 |
|---|---|---|
| Transesophageal EchocardiographyTransesophageal echocardiography images will be taken prior to and post oral gastric suction. | Diagnostic test | Cardiac Surgery with Transesophageal Echocardiography |
Primary outcome
Quality of Mid Esophageal Four Chamber Images - Pre Oral Gastric Suction
Time frame: 60 minutes
Using transesophageal echocardiography mid esophageal four chamber images will be taken prior to oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Quality of Mid Esophageal Four Chamber Images - Post Oral Gastric Suction
Time frame: 60 minutes
Using transesophageal echocardiography mid esophageal four chamber images will be taken post oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Quality of Transgastric Basal Images - Pre Oral Gastric Suction
Time frame: 60 minutes
Using transesophageal echocardiography transgastric basal images will be taken prior to oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Quality of Transgastric Basal Images - Post Gastric Suction
Time frame: 60 minutes
Using transesophageal echocardiography transgastric basal images will be taken post oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Quality of Transgastric Mid Papillary Images - Pre Oral Gastric Suction
Time frame: 60 minutes
Using transesophageal echocardiography transgastric mid images will be taken prior to oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Quality of Transgastric Mid Papillary Images - Post Oral Gastric Suction
Time frame: 60 minutes
Using transesophageal echocardiography transgastric mid images will be taken post oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Quality of Mid Esophageal Two-Chamber Images - Pre Oral Gastric Suction
Time frame: 60 minutes
Using transesophageal echocardiography mid esophageal two-chamber images will be taken prior to oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Quality of Mid Esophageal Two-Chamber Images - Post Oral Gastric Suction
Time frame: 60 minutes
Using transesophageal echocardiography mid esophageal two-chamber images will be taken post oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Quality of Deep Transgastric Images - Pre Oral Gastric Suction
Time frame: 60 minutes
Using transesophageal echocardiography deep transgastric images will be taken prior to oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Quality of Deep Transgastric Images - Post Oral Gastric Suction
Time frame: 60 minutes
Using transesophageal echocardiography deep transgastric images will be taken post oral gastric suctioning. Quality of images will be graded on a scale of 1-4 (1=excellent quality, 4=very poor quality).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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.
Scott Coleman, DO principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TEE Image Quality, run by Wake Forest University Health Sciences at 1 site in United States.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 25 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott Coleman, DO (336-716-4498, Scott.Coleman@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Mid Esophageal Four Chamber Images - Pre Oral Gastric Suction (time frame: 60 minutes). The study lists 10 primary outcomes in all. 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 25 Aug 2026.