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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: Transesophageal Echocardiography
Transesophageal echocardiography images will be taken prior to and post oral gastric suction.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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