Preoperative Gastric Volume and High-Risk Gastric Content in Patients With Type 2 Diabetes Mellitus
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Fatma Çiğdem Özakın, MD
- Número de teléfono: +905464168250
- Correo electrónico: f.cigdemulus@gmail.com
Ubicaciones de estudio
-
-
Istanbul
-
Istanbul, Istanbul, Turquía (Türkiye), 34147
- Bakırköy Dr. Sadi Konuk Training and Research Hospital
-
Contacto:
- Fatma Çiğdem Özakın, MD
- Número de teléfono: +905464168250
- Correo electrónico: f.cigdemulus@gmail.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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. |
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. 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Presence of a High-Risk Stomach
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Association Between Age and High-Risk Stomach
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Fatma Çiğdem Özakın, MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Kar Man Chan L. Gastric ultrasound: Enhancing preoperative risk assessment and patient safety. J Perioper Pract. 2025 Nov;35(11):501-503. doi: 10.1177/17504589241302220. Epub 2024 Dec 11.
- Aydin BS, Guldogan IK. Determinants of gastric residual volume before elective surgery in diabetic patients: An observational study. Saudi J Anaesth. 2024 Apr-Jun;18(2):167-172. doi: 10.4103/sja.sja_339_23. Epub 2024 Mar 14.
- Perlas A, Xiao MZX, Tomlinson G, Jacob B, Abdullah S, Kruisselbrink R, Chan VWS. Baseline Gastric Volume in Fasting Diabetic Patients Is Not Higher than That in Nondiabetic Patients: A Cross-sectional Noninferiority Study. Anesthesiology. 2024 Apr 1;140(4):648-656. doi: 10.1097/ALN.0000000000004815.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026/317
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .