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Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting

2026年11月5日 更新者:Gozde Altun、Istanbul University - Cerrahpasa

Preoperative Gastric Ultrasound Assessment and Anaesthetic Management in Adults Undergoing Elective Isolated Coronary Artery Bypass Grafting: A Multicentre Prospective Observational Study

Fasting before surgery does not always ensure that the stomach is empty. Residual gastric contents may be relevant to the risk of stomach contents entering the lungs during anaesthesia.

This multicentre prospective observational study will enrol 240 adults scheduled for elective isolated coronary artery bypass grafting at two hospitals in Türkiye. Gastric ultrasound will be performed before any sedative or anaesthetic medication is administered. The study will determine the proportion of patients with high-risk gastric contents despite routine preoperative fasting.

High-risk gastric contents will be defined as any solid or thick contents, or an estimated clear fluid volume greater than 1.5 mL/kg. Associations with patient characteristics, medical conditions, medication use and fasting duration will also be examined.

The anaesthetist's management plan will be recorded before the ultrasound findings are known. After the findings are communicated, any changes in surgical timing, anaesthetic induction, airway management or aspiration precautions will be documented. Fasting practices will not be modified for research purposes, and all clinical decisions will remain with the attending anaesthetist.

調査の概要

状態

まだ募集していません

詳細な説明

An additional secondary objective is to identify preoperative factors associated with high-risk gastric contents detected by gastric ultrasound. High-risk gastric contents will be defined as any solid or thick gastric contents or an estimated clear fluid volume greater than 1.5 mL/kg, consistent with the primary outcome definition. Candidate variables will include age, sex, body mass index, diabetes mellitus and its duration, insulin use, chronic kidney disease, gastro-oesophageal reflux disease, hypothyroidism, preoperative laboratory values and medication use specified in the study protocol, and actual solid food and clear fluid fasting durations. These data will be obtained from participant interviews and preoperative medical records. Associations will be evaluated using logistic regression and reported as odds ratios with 95% confidence intervals, where estimable. Multivariable analysis will be performed if the number of participants with high-risk gastric contents permits, with the number of included variables restricted to reduce the risk of model overfitting.

研究の種類

観察的

入学 (推定)

240

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

研究場所

      • Istanbul、トルコ(Türkiye)
        • Istanbul University-Cerrahpasa Institute of Cardiology

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

Adults aged 18 years or older scheduled for elective isolated coronary artery bypass grafting at Istanbul University-Cerrahpasa Institute of Cardiology and Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Türkiye. Patients prepared according to routine institutional preoperative fasting practices will be assessed consecutively during the recruitment period. Eligible patients who provide written informed consent will be enrolled.

説明

Inclusion Criteria:

  • Age 18 years or older.
  • Scheduled for elective isolated coronary artery bypass grafting.
  • Prepared according to routine institutional preoperative fasting practices.
  • Provision of written informed consent.

Exclusion Criteria:

  • Scheduled for emergency or urgent coronary artery bypass grafting.
  • Planned concomitant cardiac surgical procedure.
  • Body mass index of 40 kg/m² or greater.
  • Previous gastric or oesophageal surgery resulting in substantially altered gastric anatomy.
  • Gastric outlet obstruction or known mechanical gastrointestinal obstruction.
  • Inability to perform gastric ultrasound or obtain reliable measurements because of technically inadequate imaging.

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
Patients Scheduled for Elective Isolated CABG

Adults aged 18 years or older scheduled for elective isolated coronary artery bypass grafting at two participating centres, prepared according to routine institutional fasting practices. Participants will undergo preoperative gastric ultrasound before receiving any sedative or anaesthetic medication. Gastric contents and the anaesthetic management plans before and after disclosure of ultrasound findings will be recorded prospectively. All clinical decisions will remain at the discretion of the attending anaesthetist.

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
Proportion of Participants With High-Risk Gastric Contents on Preoperative Gastric Ultrasound
時間枠:During the preoperative gastric ultrasound examination, before administration of any sedative or anaesthetic medication.

Percentage of participants with high-risk gastric contents, defined as any solid or thick gastric contents or an estimated clear fluid volume greater than 1.5 mL/kg. Clear fluid volume will be estimated using the Perlas model based on the mean of three gastric antral cross-sectional area measurements obtained in the right lateral decubitus position. An empty stomach or clear fluid volume of 1.5 mL/kg or less without solid or thick contents will be classified as low risk. Perlas grade 2 alone will not define high-risk gastric contents.

During the preoperative gastric ultrasound examination, before administration of any sedative or anaesthetic medication.

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of Participants With a Change in Planned Anaesthetic Management or Surgical Timing After Disclosure of Gastric Ultrasound Findings
時間枠:On the day of planned surgery, from the assessment before gastric ultrasound to immediately after disclosure of the ultrasound findings.

Percentage of participants with a change in surgical timing, planned anaesthetic induction technique, planned intubation approach or device, or planned aspiration precautions. The management plan recorded before gastric ultrasound will be compared with the decision and revised plan recorded immediately after the findings are disclosed to the attending anaesthetist.

On the day of planned surgery, from the assessment before gastric ultrasound to immediately after disclosure of the ultrasound findings.
Proportion of Participants With a Management Change Directly Attributed to Gastric Ultrasound Findings
時間枠:Immediately after disclosure of gastric ultrasound findings, on the day of planned surgery.

Percentage of all evaluated participants whose attending anaesthetist identifies the gastric ultrasound findings as the direct reason for a change in planned anaesthetic management or surgical timing. The type of change and the clinician-reported reason will be recorded.

Immediately after disclosure of gastric ultrasound findings, on the day of planned surgery.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

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 (推定)

2026年11月30日

一次修了 (推定)

2027年5月10日

研究の完了 (推定)

2027年8月10日

試験登録日

最初に提出

2026年11月2日

QC基準を満たした最初の提出物

2026年11月5日

最初の投稿 (実際)

2026年11月6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

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

There is currently no plan to share individual participant data.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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