Coronary Artery DiseaseNCT07898215
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
An observational study of Coronary Artery Disease and Left Ventricular Systolic Dysfunction, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate whether reduced heart function is associated with differences in stomach contents before elective coronary artery bypass graft (CABG) surgery. Patients undergoing elective cardiac surgery will be divided into two groups based on their left ventricular ejection fraction (LVEF), a measure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Left Ventricular Systolic Dysfunction, Gastric Contents
- What is being tested?
- Gastric Ultrasonography
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Nov 2026to 1 Mar 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: The study population will consist of 50 adult patients (aged ≥18 years) who are scheduled for elective coronary artery bypass grafting (CABG) surgery with cardiopulmonary bypass at a single center. Eligible patients will be consecutively screened and enrolled after providing written informed consent. Participants will be categorized into two observational cohorts based on preoperative left ventricular ejection fraction (LVEF): LVEF <40% (n=25) and LVEF ≥40% (n=25). No randomization or experimental treatment assignment will be performed.
Who may be able to join
- Age ≥18 years.
- Scheduled for elective coronary artery bypass grafting (CABG) surgery with cardiopulmonary bypass.
- Willingness to participate in the study and provision of written informed consent.
Who cannot join
- Emergency surgery.
- History of upper gastrointestinal surgery.
- Known gastroparesis or severe gastrointestinal motility disorders.
- Active nausea or vomiting.
- Body mass index (BMI) >40 kg/m².
- History of gastroesophageal reflux disease (GERD).
- Inability to cooperate with gastric ultrasonography assessment.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adıyaman Training and Research Hospital
Adıyaman, 02040
FADİME TOSUN, MD, Associate Professor, +90 532 237 52 84, fadimetosun@gmail.com
About this study
Official title: Evaluation of the Relationship Between Preoperative Gastric Ultrasonography Findings and Left Ventricular Systolic Function in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery
This study aims to investigate whether reduced heart function is associated with differences in stomach contents before elective coronary artery bypass graft (CABG) surgery. Patients undergoing elective cardiac surgery will be divided into two groups based on their left ventricular ejection fraction (LVEF), a measure of how well the heart pumps blood: patients with an LVEF below 40% and patients with an LVEF of 40% or higher. Before surgery, the researchers will use ultrasound to examine the stomach. They will assess the presence and amount of stomach contents using the Perlas grading system and ultrasound measurements of the gastric antrum. The main objective is to compare gastric ultrasound findings between the two groups. The researchers will also evaluate estimated gastric volume and the frequency of stomach findings associated with a higher risk of aspiration during anesthesia.
Read the detailed description
This prospective, single-center, observational cohort study will investigate the association between left ventricular systolic function and preoperative gastric ultrasonography findings in adult patients undergoing elective coronary artery bypass grafting (CABG) surgery.
A total of 50 patients will be enrolled consecutively and categorized into two groups according to preoperative left ventricular ejection fraction (LVEF): patients with LVEF <40% (n=25) and those with LVEF ≥40% (n=25). Group allocation will be based on pre-existing cardiac function without any study-related intervention. Demographic characteristics, relevant comorbidities, preoperative medication use, gastrointestinal symptoms, fasting duration, and echocardiographic findings will be documented to evaluate potential factors associated with gastric ultrasound findings.
Preoperative gastric ultrasonography will be performed before induction of general anesthesia by an anesthesiologist experienced in point-of-care gastric ultrasound. The examiner will be blinded to the patients' clinical and echocardiographic findings, including LVEF values. A 2-5 MHz convex transducer will be used to examine the gastric antrum in the epigastric region, using standard anatomical landmarks. Gastric assessment will be performed in both the supine and right lateral decubitus (RLD) positions.
Gastric contents will be assessed qualitatively using the Perlas grading system. Grade 0 indicates an empty antrum in both positions; Grade 1 indicates clear fluid visible only in the RLD position; and Grade 2 indicates clear fluid visible in both positions or the presence of solid or particulate gastric contents.
The gastric antral cross-sectional area (CSA) will be calculated in the RLD position using the anteroposterior and craniocaudal diameters according to the formula:
CSA (cm²) = (AP diameter × CC diameter × π) / 4.
For patients with clear gastric fluid, gastric volume will be estimated using the Perlas mathematical model:
Estimated gastric volume (mL) = 27.0 + (14.6 × CSA) - (1.28 × age). Estimated gastric volume will also be expressed in mL/kg. The volume estimation model will not be applied to patients with solid or thick particulate gastric contents.
A high-risk stomach will be defined as an estimated gastric volume greater than 1.5 mL/kg or the presence of solid or thick particulate gastric contents.
The study will evaluate the association between left ventricular systolic function and preoperative gastric ultrasound findings, with particular emphasis on gastric content characteristics, antral dimensions, and indicators of increased gastric aspiration risk.
- Being tested
- Gastric Ultrasonography
- Keywords
- Gastric Ultrasonography, Coronary Artery Bypass Grafting (CABG), Left Ventricular Ejection Fraction (LVEF), Perlas Grading System, Gastric Volume
- Medical subject headings
- Coronary Artery Disease, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric UltrasonographyDiagnostic test
Preoperative gastric ultrasonography will be performed before anesthesia induction by an experienced anesthesiologist blinded to LVEF values. Using a 2-5 MHz convex probe, the gastric antrum will be examined in supine and right lateral decubitus positions. Perlas grade, antral cross-sectional area, and gastric contents will be recorded. Gastric volume will be estimated only in patients with clear fluid. A high-risk stomach will be defined as gastric volume >1.5 mL/kg or the presence of solid or thick particulate contents. The same protocol will be applied to both LVEF groups.
| Study group | Role | What they receive |
|---|---|---|
| Group L-EF - Reduced LVEF (LVEF <40%) | This cohort will include 25 adult patients scheduled for elective coronary artery bypass grafting (CABG) surgery with a preoperative left ventricular ejection fraction (LVEF) <40%, as determined by transthoracic echocardiography. Before induction of general anesthesia, patients will undergo gastric ultrasonography to assess Perlas grade, gastric antral cross-sectional area, estimated gastric volume, and the presence of high-risk gastric contents. No experimental therapeutic intervention will be administered. Receives: Diagnostic Test: Gastric Ultrasonography | |
| Group N-EF - (LVEF ≥40%) | This cohort will include 25 adult patients scheduled for elective coronary artery bypass grafting (CABG) surgery with a preoperative left ventricular ejection fraction (LVEF) ≥40%, as determined by transthoracic echocardiography. Before induction of general anesthesia, patients will undergo gastric ultrasonography to assess Perlas grade, gastric antral cross-sectional area, estimated gastric volume, and the presence of high-risk gastric contents. No experimental therapeutic intervention will be administered. Receives: Diagnostic Test: Gastric Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of Perlas Gastric Ultrasound Grades Between LVEF Groups
The primary outcome is the comparison of Perlas gastric ultrasound grade distributions between patients with LVEF <40% and LVEF ≥40%. Gastric contents will be assessed before anesthesia induction using the Perlas grading system: Grade 0, empty antrum in both supine and right lateral decubitus positions; Grade 1, clear fluid visible only in the right lateral decubitus position; and Grade 2, clear fluid visible in both positions. The number and percentage of patients in each grade will be compared between groups.
Measured: Preoperatively, immediately before induction of general anesthesia
Secondary outcomes (4)
Association Between LVEF and Estimated Gastric Volume (mL/kg)
The association between left ventricular ejection fraction (LVEF) and estimated gastric volume (mL/kg) will be evaluated in patients with clear gastric fluid. Gastric volume will be calculated using the Perlas formula: 27.0 + (14.6 × antral cross-sectional area in cm²) - (1.28 × age in years). The estimated volume will be divided by body weight to obtain mL/kg. The formula will not be applied to patients with solid or thick particulate gastric contents.
Measured: Preoperatively, immediately before induction of general anesthesia
Gastric Antral Cross-Sectional Area (CSA)
Gastric antral cross-sectional area (CSA) will be measured using preoperative ultrasonography in the right lateral decubitus position. CSA will be calculated from the anteroposterior and craniocaudal diameters using the formula: CSA = (AP diameter × CC diameter × π) / 4. CSA values, expressed in cm², will be compared between patients with LVEF <40% and those with LVEF ≥40%.
Measured: Preoperatively, immediately before induction of general anesthesia
Presence of Solid Gastric Contents
The presence of solid or thick particulate gastric contents will be assessed using preoperative gastric ultrasonography in the supine and right lateral decubitus positions. Findings will be recorded as present or absent. The number and percentage of patients with solid or thick particulate gastric contents will be compared between the LVEF <40% and LVEF ≥40% groups.
Measured: Preoperatively, immediately before induction of general anesthesia
Prevalence of High-Risk Gastric Contents
A high-risk stomach will be defined as an estimated gastric volume >1.5 mL/kg or the presence of solid or thick particulate gastric contents on preoperative ultrasonography. Gastric volume will be estimated only in patients with clear fluid contents. The number and percentage of patients meeting the high-risk stomach criteria will be compared between the LVEF <40% and LVEF ≥40% groups.
Measured: Preoperatively, immediately before induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start4 Nov 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadime Tosun, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898215
- Sponsor's protocol ID
- ADYU-AR-FT-04
- Status last verified
- Nov 2026
- First submitted
- 21 Oct 2026
- Last updated
- 6 Nov 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Preoperative Gastric Ultrasonography Findings and Left Ventricular Systolic Function in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT07898215
- Acronym / sponsor ID
- ADYU-AR-FT-04
- Keywords
- Gastric Ultrasonography, Coronary Artery Bypass Grafting (CABG), Left Ventricular Ejection Fraction (LVEF), Perlas Grading System, Gastric Volume
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 4 Nov 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
This study aims to investigate whether reduced heart function is associated with differences in stomach contents before elective coronary artery bypass graft (CABG) surgery. Patients undergoing elective cardiac surgery will be divided into two groups based on their left ventricular ejection fraction (LVEF), a measure of how well the heart pumps blood: patients with an LVEF below 40% and patients with an LVEF of 40% or higher. Before surgery, the researchers will use ultrasound to examine the stomach. They will assess the presence and amount of stomach contents using the Perlas grading system and ultrasound measurements of the gastric antrum. The main objective is to compare gastric ultrasound findings between the two groups. The researchers will also evaluate estimated gastric volume and the frequency of stomach findings associated with a higher risk of aspiration during anesthesia.
Detailed description
This prospective, single-center, observational cohort study will investigate the association between left ventricular systolic function and preoperative gastric ultrasonography findings in adult patients undergoing elective coronary artery bypass grafting (CABG) surgery.
A total of 50 patients will be enrolled consecutively and categorized into two groups according to preoperative left ventricular ejection fraction (LVEF): patients with LVEF <40% (n=25) and those with LVEF ≥40% (n=25). Group allocation will be based on pre-existing cardiac function without any study-related intervention. Demographic characteristics, relevant comorbidities, preoperative medication use, gastrointestinal symptoms, fasting duration, and echocardiographic findings will be documented to evaluate potential factors associated with gastric ultrasound findings.
Preoperative gastric ultrasonography will be performed before induction of general anesthesia by an anesthesiologist experienced in point-of-care gastric ultrasound. The examiner will be blinded to the patients' clinical and echocardiographic findings, including LVEF values. A 2-5 MHz convex transducer will be used to examine the gastric antrum in the epigastric region, using standard anatomical landmarks. Gastric assessment will be performed in both the supine and right lateral decubitus (RLD) positions.
Gastric contents will be assessed qualitatively using the Perlas grading system. Grade 0 indicates an empty antrum in both positions; Grade 1 indicates clear fluid visible only in the RLD position; and Grade 2 indicates clear fluid visible in both positions or the presence of solid or particulate gastric contents.
The gastric antral cross-sectional area (CSA) will be calculated in the RLD position using the anteroposterior and craniocaudal diameters according to the formula:
CSA (cm²) = (AP diameter × CC diameter × π) / 4.
For patients with clear gastric fluid, gastric volume will be estimated using the Perlas mathematical model:
Estimated gastric volume (mL) = 27.0 + (14.6 × CSA) - (1.28 × age). Estimated gastric volume will also be expressed in mL/kg. The volume estimation model will not be applied to patients with solid or thick particulate gastric contents.
A high-risk stomach will be defined as an estimated gastric volume greater than 1.5 mL/kg or the presence of solid or thick particulate gastric contents.
The study will evaluate the association between left ventricular systolic function and preoperative gastric ultrasound findings, with particular emphasis on gastric content characteristics, antral dimensions, and indicators of increased gastric aspiration risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L-EF - Reduced LVEF (LVEF <40%) | – | Diagnostic Test: Gastric UltrasonographyThis cohort will include 25 adult patients scheduled for elective coronary artery bypass grafting (CABG) surgery with a preoperative left ventricular ejection fraction (LVEF) <40%, as determined by transthoracic echocardiography. Before induction of general anesthesia, patients will undergo gastric ultrasonography to assess Perlas grade, gastric antral cross-sectional area, estimated gastric volume, and the presence of high-risk gastric contents. No experimental therapeutic intervention will be administered. |
| Group N-EF - (LVEF ≥40%) | – | Diagnostic Test: Gastric UltrasonographyThis cohort will include 25 adult patients scheduled for elective coronary artery bypass grafting (CABG) surgery with a preoperative left ventricular ejection fraction (LVEF) ≥40%, as determined by transthoracic echocardiography. Before induction of general anesthesia, patients will undergo gastric ultrasonography to assess Perlas grade, gastric antral cross-sectional area, estimated gastric volume, and the presence of high-risk gastric contents. No experimental therapeutic intervention will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 50 adult patients (aged ≥18 years) who are scheduled for elective coronary artery bypass grafting (CABG) surgery with cardiopulmonary bypass at a single center. Eligible patients will be consecutively screened and enrolled after providing written informed consent. Participants will be categorized into two observational cohorts based on preoperative left ventricular ejection fraction (LVEF): LVEF <40% (n=25) and LVEF ≥40% (n=25). No randomization or experimental treatment assignment will be performed.
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Scheduled for elective coronary artery bypass grafting (CABG) surgery with cardiopulmonary bypass.
- Willingness to participate in the study and provision of written informed consent.
Key exclusion criteria (8 listed)
- Emergency surgery.
- History of upper gastrointestinal surgery.
- Known gastroparesis or severe gastrointestinal motility disorders.
- Active nausea or vomiting.
- Body mass index (BMI) >40 kg/m².
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 |
|---|---|---|
| Gastric UltrasonographyPreoperative gastric ultrasonography will be performed before anesthesia induction by an experienced anesthesiologist blinded to LVEF values. Using a 2-5 MHz convex probe, the gastric antrum will be examined in supine and right lateral decubitus positions. Perlas grade, antral cross-sectional area, and gastric contents will be recorded. Gastric volume will be estimated only in patients with clear fluid. A high-risk stomach will be defined as gastric volume >1.5 mL/kg or the presence of solid or thick particulate contents. The same protocol will be applied to both LVEF groups. | Diagnostic test | Group L-EF - Reduced LVEF (LVEF <40%), Group N-EF - (LVEF ≥40%) |
Primary outcome
Distribution of Perlas Gastric Ultrasound Grades Between LVEF Groups
Time frame: Preoperatively, immediately before induction of general anesthesia
The primary outcome is the comparison of Perlas gastric ultrasound grade distributions between patients with LVEF <40% and LVEF ≥40%. Gastric contents will be assessed before anesthesia induction using the Perlas grading system: Grade 0, empty antrum in both supine and right lateral decubitus positions; Grade 1, clear fluid visible only in the right lateral decubitus position; and Grade 2, clear fluid visible in both positions. The number and percentage of patients in each grade will be compared between groups.
4 secondary outcomes
Association Between LVEF and Estimated Gastric Volume (mL/kg)
Time frame: Preoperatively, immediately before induction of general anesthesia
Gastric Antral Cross-Sectional Area (CSA)
Time frame: Preoperatively, immediately before induction of general anesthesia
Presence of Solid Gastric Contents
Time frame: Preoperatively, immediately before induction of general anesthesia
Prevalence of High-Risk Gastric Contents
Time frame: Preoperatively, immediately before induction of general anesthesia
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 6 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
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.
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 Coronary Artery Disease and Left Ventricular Systolic Dysfunction, run by Adiyaman University at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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 6 Nov 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 Turkey (Türkiye). 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 FADİME TOSUN, MD, Associate Professor (+90 532 237 52 84, fadimetosun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of Perlas Gastric Ultrasound Grades Between LVEF Groups (time frame: Preoperatively, immediately before induction of general anesthesia). 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 6 Nov 2026.