- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07209293
- Original Trial
Oral Gastric Suctioning Effect on Transesophageal Echo
October 24, 2025 updated by: Wake Forest University Health Sciences
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Scott Coleman, DO
- Phone Number: 336-716-4498
- Email: Scott.Coleman@advocatehealth.org
Study Contact Backup
- Name: Lynnette Harris, BSN
- Phone Number: 336-716-8791
- Email: lynnette.harris@advocatehealth.org
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Atrium Health-Wake Forest Baptist
-
Contact:
- Scott R Coleman, DO
- Phone Number: 336-716-4498
- Email: Scott.Coleman@advocatehealth.org
-
Contact:
- Lynnette C. Harris, BSN
- Phone Number: 336-716-8791
- Email: lynnettte.harris@advocatehealth.org
-
Principal Investigator:
- Scott R Coleman, DO
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients scheduled for cardiac surgery at Atrium Health Wake Forest Baptist
Description
Inclusion Criteria:
- Transesophageal echocardiography assisted cardiac surgery
Exclusion Criteria:
- hiatal hernia
- documented or suspected esophageal stricture
- contraindications to a TEE
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Transesophageal echocardiography images will be taken prior to and post oral gastric suction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
60 minutes
|
|
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).
|
60 minutes
|
|
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).
|
60 minutes
|
|
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).
|
60 minutes
|
|
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).
|
60 minutes
|
|
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).
|
60 minutes
|
|
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).
|
60 minutes
|
|
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).
|
60 minutes
|
|
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).
|
60 minutes
|
|
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).
|
60 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Scott Coleman, DO, Wake Forest University Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 22, 2025
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
October 30, 2026
Study Registration Dates
First Submitted
September 30, 2025
First Submitted That Met QC Criteria
September 30, 2025
First Posted (Estimated)
October 6, 2025
Study Record Updates
Last Update Posted (Estimated)
October 28, 2025
Last Update Submitted That Met QC Criteria
October 24, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00137024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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