An observational study in Diabetes Mellitus ( Type 1 and Type 2), Respiratory Aspiration and Gastroparesis, sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Observational
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.
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.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 130 is below the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital is the lead sponsor of 59 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Residual Gastric Volume Assessed by Preoperative Gastric Ultrasound
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.
Time frame: Preoperatively, before induction of anesthesia (single assessment)
Prevalence of High Aspiration Risk
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
Time frame: Preoperatively, before induction of anesthesia (single assessment)
Correlation Between HbA1c and Gastric Volume
Correlation between preoperative HbA1c level (%) and weight-normalized gastric volume (mL/kg), assessed using Pearson or Spearman correlation coefficient.
Time frame: Preoperatively, before induction of anesthesia (single assessment)
Correlation Between Diabetes Duration and Gastric Volume
Correlation between duration of diabetes mellitus (years) and weight-normalized gastric volume (mL/kg), assessed using Pearson or Spearman correlation coefficient.
Time frame: Preoperatively, before induction of anesthesia (single assessment)
Effect of GLP-1 Receptor Agonist Use and Timing of Last Dose on Gastric Volume
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
Time frame: Preoperatively, before induction of anesthesia (single assessment)
Effect of Insulin Use on Gastric Volume
Weight-normalized gastric volume (mL/kg) compared between patients using and not using insulin therapy.
Time frame: Preoperatively, before induction of anesthesia (single assessment)
Correlation Between Preoperative Fasting Duration and Gastric Volume
Correlation between preoperative solid and clear fluid fasting durations (hours) and weight-normalized gastric volume (mL/kg), assessed using Pearson or Spearman correlation coefficient.
Time frame: Preoperatively, before induction of anesthesia (single assessment)
Correlation Between Gastroparesis Cardinal Symptom Index (GCSI) Score and Gastric Volume
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.
Time frame: Preoperatively, before induction of anesthesia (single assessment)
Incidence of Postoperative Clinical Aspiration
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.
Time frame: Up to 48 hours after surgery
Plan to share: No — Individual participant data will not be shared due to patient confidentiality and data protection regulations. Aggregate results will be reported in the publication.
Start is estimated for Dec 2026; primary completion for Jun 2027, 6 months later.
Of 533 non-industry observational studies under Diabetes Mellitus, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 175. This study's planned 6 months is below that.
Counting every sponsor, half of 642 studies reached it within 36 months; a quarter within 14 and three quarters within 122.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital