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Preoperative Gastric Volume and High-Risk Gastric Content in Patients With Type 2 Diabetes Mellitus

26. September 2026 aktualisiert von: Fatma Cigdem Ozakin, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Clinical and Metabolic Determinants of High Residual Gastric Volume in Patients With Type 2 Diabetes Mellitus

This prospective observational study will evaluate adult patients with type 2 diabetes mellitus who are scheduled for elective surgery. Immediately before preoperative gastric ultrasonography, capillary fasting blood glucose will be measured.

Gastric contents will be assessed qualitatively in the supine and right lateral decubitus positions, and residual gastric volume will be estimated using the antral cross-sectional area measured in the right lateral decubitus position.

The primary objective is to evaluate the association between fasting capillary blood glucose and the presence of a high-risk stomach. A high-risk stomach will be defined as the presence of solid gastric contents, Perlas Grade 2 gastric contents, or an estimated gastric volume greater than 1.5 mL/kg.

Secondary objectives include determining the prevalence of a high-risk stomach and evaluating its associations with demographic characteristics, diabetes-related factors, comorbidities, fasting duration, medication use, gastroparesis-related symptoms, and routine laboratory parameters.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This is a single-center, prospective observational study involving adult patients with type 2 diabetes mellitus scheduled for elective surgery.

On the day of surgery, participants will be evaluated in the preoperative preparation area before anesthesia induction and before administration of sedative premedication. Demographic data, diabetes duration and treatment, diabetes-related complications, comorbidities, smoking status, symptoms potentially associated with gastroparesis, fasting duration, and routinely available laboratory parameters will be recorded.

Capillary fasting blood glucose will be measured immediately before gastric ultrasonography and will constitute the primary independent variable.

Gastric ultrasonography will be performed by a trained and experienced investigator using a low-frequency convex transducer. The gastric antrum will be assessed first in the supine position and then in the right lateral decubitus position. Gastric contents will be classified as empty, clear fluid, or solid content. Clear fluid findings will additionally be classified according to the Perlas grading system.

For quantitative assessment, anteroposterior and craniocaudal diameters of the gastric antrum will be measured and the antral cross-sectional area will be calculated. Estimated gastric volume will be calculated from the right lateral decubitus antral cross-sectional area and expressed both in mL and mL/kg.

A high-risk stomach will be defined by at least one of the following findings: solid gastric contents, clear fluid visible in both the supine and right lateral decubitus positions (Perlas Grade 2), or estimated gastric volume greater than 1.5 mL/kg.

No experimental treatment or additional invasive intervention will be administered as part of the study. If clinically relevant high-risk gastric findings are identified, the responsible anesthesia team will be informed and subsequent anesthetic management will be determined by the clinical team.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

120

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Türkei (türkiye)
    • Istanbul
      • Istanbul, Istanbul, Türkei (türkiye), 34147
        • Bakırköy Dr. Sadi Konuk Training and Research Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Adult patients with type 2 diabetes mellitus who are scheduled for elective surgery at University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital and who meet the study eligibility criteria.

Beschreibung

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosis of type 2 diabetes mellitus
  • American Society of Anesthesiologists (ASA) physical status II or III
  • Scheduled for elective surgery
  • Suitable for preoperative gastric ultrasonography
  • Provision of written informed consent

Exclusion Criteria:

  • Pregnancy
  • Body mass index ≥40 kg/m²
  • Emergency surgery
  • History of gastric, esophageal, or upper gastrointestinal surgery
  • Presence of a nasogastric tube
  • Known gastroparesis or gastric outlet obstruction
  • Active vomiting
  • Systemic opioid or prokinetic drug use within the previous 72 hours
  • Anatomical or technical conditions preventing adequate gastric ultrasonographic assessment
  • Impaired consciousness or inability to provide a reliable medical history
  • Refusal to participate in the study

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: COHORT
  • Zeitperspektiven: PROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Preoperative Patients With Type 2 Diabetes Mellitus

Adult patients with type 2 diabetes mellitus, ASA physical status II or III, who are scheduled for elective surgery and undergo preoperative gastric ultrasonography and capillary fasting blood glucose measurement.
Diagnosetest: Preoperative Gastric Ultrasonography

The gastric antrum will be evaluated in the supine and right lateral decubitus positions before anesthesia induction and sedative premedication. Gastric contents will be assessed qualitatively, and antral cross-sectional area and estimated residual gastric volume will be calculated quantitatively.

Diagnosetest: Capillary Fasting Blood Glucose Measurement

Capillary fasting blood glucose will be measured by fingertip sampling immediately before gastric ultrasonography. The measured glucose concentration will be evaluated as the primary exposure variable in relation to high-risk gastric findings.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Presence of a High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment immediately before anesthesia induction

A high-risk stomach will be defined as the presence of at least one of the following findings on preoperative gastric ultrasonography: solid gastric contents; clear fluid visible in both the supine and right lateral decubitus positions (Perlas Grade 2); or an estimated gastric volume greater than 1.5 mL/kg.
On the day of surgery, during the preoperative assessment immediately before anesthesia induction

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Association Between Age and High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment before anesthesia induction

Age will be recorded in years from the patient's medical record. The association between age and the presence of a high-risk stomach (yes/no) will be evaluated .
On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Sex and High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment before anesthesia induction

Sex will be recorded as male or female from the patient's medical record. The association between sex and the presence of a high-risk stomach (yes/no) will be evaluated.
On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Body Mass Index and High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment before anesthesia induction

Body mass index will be calculated as body weight in kilograms divided by height in meters squared and reported in kg/m². The association between body mass index and the presence of a high-risk stomach (yes/no) will be evaluated.
On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Duration of Type 2 Diabetes Mellitus and High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment before anesthesia induction

Duration of type 2 diabetes mellitus will be recorded in years based on the patient's medical history and medical records. Its association with the presence of a high-risk stomach (yes/no) will be evaluated.
On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Diabetes-Related Complications and High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment before anesthesia induction

The presence of diabetes related target organ complications will be determined from the patient's medical history and medical records and recorded as present or absent. The association between the presence of diabetes-related complications and a high-risk stomach (yes/no) will be evaluated.
On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Comorbidities and High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment before anesthesia induction

The presence of comorbidity will be assessed from the patient's medical history and medical records. Prespecified comorbidities will include hypertension, gastroesophageal reflux disease, obstructive sleep apnea, hypothyroidism, chronic kidney disease, dialysis treatment, and liver dysfunction. Participants will be classified according to the presence or absence of at least one of these comorbidities. The association between the presence of any prespecified comorbidity and a high-risk stomach (yes/no) will be evaluated.
On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Gastroparesis-Related Symptoms and High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment before anesthesia induction

Gastroparesis-related symptoms will be assessed by preoperative patient interview. Prespecified symptoms will include loss of appetite, early satiety, and postprandial fullness. Participants will be classified according to the presence or absence of at least one of these symptoms. The association between the presence of any gastroparesis-related symptom and a high-risk stomach (yes/no) will be evaluated.
On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Solid Food Fasting Duration and High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment before anesthesia induction

The time elapsed since the last solid food intake will be determined from the patient's history and clinical records and recorded in hours. Its association with the presence of a high-risk stomach (yes/no) will be evaluated.
On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Clear Fluid Fasting Duration and High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment before anesthesia induction

The time elapsed since the last clear fluid intake will be determined from the patient's history and clinical records and recorded in hours. Its association with the presence of a high-risk stomach (yes/no) will be evaluated.
On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Smoking Status and High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment before anesthesia induction

Smoking status will be assessed by patient interview and categorized as current smoker, former smoker, or never smoker. The association between smoking status and the presence of a high-risk stomach (yes/no) will be evaluated.
On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Antidiabetic Medication Use and High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment before anesthesia induction

Current antidiabetic medication use will be determined from the patient's medication history and medical records. Antidiabetic medications will include oral antidiabetic drugs, insulin, GLP-1 receptor agonists, and SGLT-2 inhibitors. Participants will be classified according to the presence or absence of current use of at least one antidiabetic medication. The association between any current antidiabetic medication use and the presence of a high-risk stomach (yes/no) will be evaluated.
On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Proton Pump Inhibitor Use and High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment before anesthesia induction

Proton pump inhibitor use will be determined from the patient's medication history and recorded as yes or no. Its association with the presence of a high-risk stomach (yes/no) will be evaluated.
On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between HbA1c and High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment before anesthesia induction

HbA1c will be obtained from routine preoperative laboratory results and recorded as a percentage (%). The association between HbA1c and the presence of a high-risk stomach (yes/no) will be evaluated.
On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Hemoglobin Level and High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment before anesthesia induction

Hemoglobin concentration will be obtained from routine preoperative laboratory results and recorded in g/dL. The association between hemoglobin concentration and the presence of a high-risk stomach (yes/no) will be evaluated.
On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Blood Urea Level and High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment before anesthesia induction

Blood urea concentration will be obtained from routine preoperative laboratory results and recorded in mg/dL. The association between blood urea concentration and the presence of a high-risk stomach (yes/no) will be evaluated.
On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Serum Creatinine Level and High-Risk Stomach
Zeitfenster: On the day of surgery, during the preoperative assessment before anesthesia induction

Serum creatinine concentration will be obtained from routine preoperative laboratory results and recorded in mg/dL. The association between serum creatinine concentration and the presence of a high-risk stomach (yes/no) will be evaluated.
On the day of surgery, during the preoperative assessment before anesthesia induction

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Ermittler

  • Hauptermittler: Fatma Çiğdem Özakın, MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. April 2027

Studienabschluss (Geschätzt)

1. April 2027

Studienanmeldedaten

Zuerst eingereicht

21. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. September 2026

Zuerst gepostet (Tatsächlich)

25. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026/317

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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