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Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery

2026年11月5日 更新者:Fadime Tosun、Adiyaman University

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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (推定)

50

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:FADİME TOSUN, MD, Associate Professor
  • 電話番号:+90 532 237 52 84
  • メール:fadimetosun@gmail.com

研究場所

      • Adıyaman、トルコ(Türkiye)、02040
        • 募集
        • Adıyaman Training and Research Hospital
        • コンタクト:
          • FADİME TOSUN, MD, Associate Professor
          • 電話番号:+90 532 237 52 84
          • メール:fadimetosun@gmail.com

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:COHORT
  • 時間の展望:PROSPECTIVE

コホートと介入

グループ/コホート
介入・治療
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.

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.

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.

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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Distribution of Perlas Gastric Ultrasound Grades Between LVEF Groups
時間枠: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.

Preoperatively, immediately before induction of general anesthesia

二次結果の測定

結果測定
メジャーの説明
時間枠
Association Between LVEF and Estimated Gastric Volume (mL/kg)
時間枠:Preoperatively, immediately before induction of general anesthesia

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.

Preoperatively, immediately before induction of general anesthesia
Gastric Antral Cross-Sectional Area (CSA)
時間枠:Preoperatively, immediately before induction of general anesthesia

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%.

Preoperatively, immediately before induction of general anesthesia
Presence of Solid Gastric Contents
時間枠:Preoperatively, immediately before induction of general anesthesia

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.

Preoperatively, immediately before induction of general anesthesia
Prevalence of High-Risk Gastric Contents
時間枠:Preoperatively, immediately before induction of general anesthesia

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.

Preoperatively, immediately before induction of general anesthesia

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スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年11月4日

一次修了 (推定)

2027年3月1日

研究の完了 (推定)

2027年3月1日

試験登録日

最初に提出

2026年10月21日

QC基準を満たした最初の提出物

2026年10月21日

最初の投稿 (実際)

2026年10月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月6日

QC基準を満たした最後の更新が送信されました

2026年11月5日

最終確認日

2026年11月1日

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