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Preoperative Gastric Ultrasound to Assess Stomach Contents and Aspiration Risk in Patients With Diabetes

Diabetes Mellitus ( Type 1 and Type 2) · Respiratory Aspiration · Gastroparesis

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
Observacional
Fase
No aplica / no indicada
Rango de edad
18 años - 80 años
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
130 Estimado

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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

Diabetes can slow down stomach emptying. As a result, some patients with diabetes may still have food or fluid in their stomach before surgery, even after following standard fasting rules. This can increase the risk of stomach contents entering the lungs (pulmonary aspiration) during anesthesia.

The aim of this prospective observational study is to measure the amount of residual stomach content using bedside gastric ultrasound in adult patients with type 1 or type 2 diabetes scheduled for elective surgery under general anesthesia. The study will also determine how often a high aspiration risk is present and identify clinical factors associated with it, including HbA1c level, duration of diabetes, use of GLP-1 receptor agonists, insulin use, fasting duration, and gastroparesis symptoms.

Gastric ultrasound is non-invasive, painless, and does not involve radiation. No drug or additional intervention will be given as part of this study. Patients found to be at high aspiration risk will be reported to the responsible anesthesiologist.

Leer la descripción completa

This is a prospective, observational, single-center study to be conducted at the University of Health Sciences Gazi Yasargil Training and Research Hospital. Approximately 130 adult patients (aged 18-80 years, ASA physical status I-III) with type 1 or type 2 diabetes mellitus scheduled for elective surgery under general anesthesia will be enrolled after written informed consent.

Each patient will be assessed at a single time point in the preoperative holding area before induction of anesthesia. Gastric ultrasound will be performed in the supine and right lateral decubitus positions. The anteroposterior and craniocaudal diameters of the gastric antrum will be measured, and the antral cross-sectional area (CSA) will be calculated. Gastric volume (GV) will be estimated using the Perlas formula \[GV (mL) = 27 + 14.6 x CSA - 1.28 x age\] and normalized to body weight (mL/kg). Gastric content will be classified according to the Perlas grading system (Grade 0-2). Patients with Perlas Grade 2 and/or GV \>1.5 mL/kg will be classified as having high aspiration risk.

Demographic data, diabetes-related clinical parameters (type and duration of diabetes, HbA1c, fasting blood glucose, insulin and oral antidiabetic use), details of GLP-1 receptor agonist use (drug, dose, frequency, and time since last dose), preoperative fasting durations, and gastroparesis symptoms assessed with the Gastroparesis Cardinal Symptom Index (GCSI) will be recorded by a second investigator.

To minimize measurement bias, the ultrasound examination will be performed by a single trained anesthesiologist blinded to the patients' clinical data, while the investigator collecting clinical data will be blinded to the ultrasound findings.

Patients will be followed for 24-48 hours postoperatively through medical records for postoperative nausea and vomiting, fever, cough, dyspnea, pulmonary infiltrates on chest radiography, and clinical signs of aspiration pneumonia.

Factors associated with high aspiration risk will be analyzed using univariable and multivariable logistic regression. Correlations between gastric volume and HbA1c, diabetes duration, fasting duration, and GCSI score will be assessed using Pearson or Spearman correlation.

¿Quién podría participar?

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Inclusion Criteria:

  • Age 18-80 years
  • Diagnosis of type 1 or type 2 diabetes mellitus
  • Scheduled for elective surgery under general anesthesia
  • ASA physical status I-III
  • Written informed consent

Exclusion Criteria:

  • Emergency surgery
  • Pregnancy
  • History of upper gastrointestinal surgery
  • Known gastrointestinal obstruction
  • Known severe gastroparesis
  • Inadequate gastric ultrasound image quality
  • Refusal to provide consent

Población del estudio

Adult patients with type 1 or type 2 diabetes mellitus scheduled for elective surgery under general anesthesia at the University of Health Sciences Gazi Yasargil Training and Research Hospital.

Entiende la evaluación inicial

Tratamiento, grupos y participación

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Asignación
No informado
Enmascaramiento
No informado
Diabetic Patients Undergoing Elective Surgery

dult patients (18-80 years, ASA physical status I-III) with type 1 or type 2 diabetes mellitus scheduled for elective surgery under general anesthesia, who will undergo a single preoperative gastric ultrasound assessment and 24-48 hours of postoperative follow-up for clinical signs of aspiration.

Diagnostic Test: Preoperative Gastric Ultrasound

Preoperative Gastric Ultrasound DIAGNOSTIC_TEST

Bedside gastric ultrasound performed in the supine and right lateral decubitus positions in the preoperative holding area before induction of anesthesia. The antral cross-sectional area will be measured, gastric volume will be calculated using the Perlas formula and normalized to body weight (mL/kg), and gastric content will be classified using the Perlas grading system. The examination is non-invasive and part of a single assessment; no drug or treatment is administered.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Residual Gastric Volume Assessed by Preoperative Gastric Ultrasound

Plazo: Preoperatively, before induction of anesthesia (single assessment)

Gastric ultrasound will be performed in both the supine and right lateral decubitus positions. Gastric volume will be estimated from the antral cross-sectional area measured in the right lateral decubitus position using the Perlas formula \[GV (mL) = 27 + 14.6 x CSA - 1.28 x age\] and normalized to body weight (mL/kg). The distribution of residual gastric volume will be reported as mean, standard deviation, median, interquartile range, and minimum-maximum values.

Medidas secundarias

Prevalence of High Aspiration Risk

Plazo: Preoperatively, before induction of anesthesia (single assessment)

Proportion of patients classified as having high aspiration risk, defined as Perlas Grade 2 (fluid visible in both supine and right lateral decubitus positions) and/or gastric volume \>1.5 mL/kg. Prevalence will be reported with 95% confidence interval

Correlation Between HbA1c and Gastric Volume

Plazo: Preoperatively, before induction of anesthesia (single assessment)

Correlation between preoperative HbA1c level (%) and weight-normalized gastric volume (mL/kg), assessed using Pearson or Spearman correlation coefficient.

Correlation Between Diabetes Duration and Gastric Volume

Plazo: Preoperatively, before induction of anesthesia (single assessment)

Correlation between duration of diabetes mellitus (years) and weight-normalized gastric volume (mL/kg), assessed using Pearson or Spearman correlation coefficient.

Effect of GLP-1 Receptor Agonist Use and Timing of Last Dose on Gastric Volume

Plazo: Preoperatively, before induction of anesthesia (single assessment)

Weight-normalized gastric volume (mL/kg) compared between GLP-1 receptor agonist users and non-users. Among users, gastric volume will be compared between patients whose last dose was taken ≤7 days and \>7 days before the preoperative assessment

Effect of Insulin Use on Gastric Volume

Plazo: Preoperatively, before induction of anesthesia (single assessment)

Weight-normalized gastric volume (mL/kg) compared between patients using and not using insulin therapy.

Correlation Between Preoperative Fasting Duration and Gastric Volume

Plazo: Preoperatively, before induction of anesthesia (single assessment)

Correlation between preoperative solid and clear fluid fasting durations (hours) and weight-normalized gastric volume (mL/kg), assessed using Pearson or Spearman correlation coefficient.

Correlation Between Gastroparesis Cardinal Symptom Index (GCSI) Score and Gastric Volume

Plazo: Preoperatively, before induction of anesthesia (single assessment)

Correlation between total GCSI score (range 0-5, higher scores indicate more severe gastroparesis symptoms) and weight-normalized gastric volume (mL/kg), assessed using Pearson or Spearman correlation coefficient.

Incidence of Postoperative Clinical Aspiration

Plazo: Up to 48 hours after surgery

Number of patients developing clinical signs of pulmonary aspiration (fever, cough, dyspnea, new pulmonary infiltrate on chest radiography) or aspiration pneumonia, and postoperative nausea and vomiting, assessed from medical records.

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Centros de investigación (1)

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1 centros

University of Health Sciences Gazi Yasargil Training and Research HospitalDiyarbakır, Diyarbakır, Turkey (Türkiye)Estado desconocido

Equipo y fechas

Patrocinador principal
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Inicio del estudio
15 dic 2026 Estimado
Finalización primaria
30 jun 2027 Estimado
Finalización del estudio
30 jun 2027 Estimado
Primera publicación
10 nov 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Título oficial del estudio

Distribution of Residual Gastric Volume Assessed by Preoperative Gastric Ultrasound, Aspiration Risk, and Related Factors in Diabetic Patients Undergoing Elective Surgery: A Prospective Observational Study

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026