NCT07209293

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Oct 2025Oct 2026

First Submitted

Initial submission to the registry

September 30, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

October 22, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

October 28, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 30, 2025

Last Update Submit

October 24, 2025

Conditions

Keywords

gastric suctiontransesophageal echocardiographycardiac surgery

Outcome Measures

Primary Outcomes (10)

  • 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).

    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).

    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).

    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).

    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).

    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).

    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).

    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).

    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).

    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).

    60 minutes

Study Arms (1)

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

Interventions

Transesophageal echocardiography images will be taken prior to and post oral gastric suction.

Cardiac Surgery with Transesophageal Echocardiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for cardiac surgery at Atrium Health Wake Forest Baptist

You may qualify if:

  • \- Transesophageal echocardiography assisted cardiac surgery

You may not qualify if:

  • hiatal hernia
  • documented or suspected esophageal stricture
  • contraindications to a TEE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atrium Health-Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Interventions

Echocardiography, Transesophageal

Intervention Hierarchy (Ancestors)

EchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Scott Coleman, DO

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2025

First Posted

October 6, 2025

Study Start

October 22, 2025

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

October 28, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations