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

4. november 2026 oppdatert av: Renim Yüksel, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

130

Kontakter og plasseringer

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Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
    • Diyarbakır
      • Diyarbakır, Diyarbakır, Tyrkia (Türkiye), 21070
        • University of Health Sciences Gazi Yasargil Training and Research Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Diagnostisk 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Residual Gastric Volume Assessed by Preoperative Gastric Ultrasound
Tidsramme: 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.
Preoperatively, before induction of anesthesia (single assessment)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prevalence of High Aspiration Risk
Tidsramme: 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
Preoperatively, before induction of anesthesia (single assessment)
Correlation Between HbA1c and Gastric Volume
Tidsramme: 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.
Preoperatively, before induction of anesthesia (single assessment)
Correlation Between Diabetes Duration and Gastric Volume
Tidsramme: 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.
Preoperatively, before induction of anesthesia (single assessment)
Effect of GLP-1 Receptor Agonist Use and Timing of Last Dose on Gastric Volume
Tidsramme: 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
Preoperatively, before induction of anesthesia (single assessment)
Effect of Insulin Use on Gastric Volume
Tidsramme: Preoperatively, before induction of anesthesia (single assessment)

Weight-normalized gastric volume (mL/kg) compared between patients using and not using insulin therapy.
Preoperatively, before induction of anesthesia (single assessment)
Correlation Between Preoperative Fasting Duration and Gastric Volume
Tidsramme: 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.
Preoperatively, before induction of anesthesia (single assessment)
Correlation Between Gastroparesis Cardinal Symptom Index (GCSI) Score and Gastric Volume
Tidsramme: 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.
Preoperatively, before induction of anesthesia (single assessment)
Incidence of Postoperative Clinical Aspiration
Tidsramme: 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.
Up to 48 hours after surgery

Samarbeidspartnere og etterforskere

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Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Etterforskere

  • Hovedetterforsker: RENİM YÜKSEL, MD, University of Health Sciences, Gazi Yasargil Training and Research Hospital

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. desember 2026

Primær fullføring (Antatt)

30. juni 2027

Studiet fullført (Antatt)

30. juni 2027

Datoer for studieregistrering

Først innsendt

4. november 2026

Først innsendt som oppfylte QC-kriteriene

4. november 2026

Først lagt ut (Faktiske)

10. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 441

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared due to patient confidentiality and data protection regulations. Aggregate results will be reported in the publication.

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