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Recruiting NCT07375680

HbA1c Levels and Gastric Emptying Assessed by Gastric Ultrasound

Observational Delayed Gastric Emptying Diabetes Mellitus Pulmonary Aspiration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Delayed Gastric Emptying, Diabetes Mellitus, Pulmonary Aspiration. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of the Effect of Hemoglobin A1c Levels on Gastric Emptying Assessed by Gastric Ultrasound

Overview

Delayed gastric emptying increases the risk of pulmonary aspiration during general anesthesia. Diabetes mellitus and poor long-term glycemic control have been associated with impaired gastric motility. Hemoglobin A1c (HbA1c) is a marker of long-term glycemic control; however, its relationship with gastric emptying in surgical patients is not fully understood. This prospective observational study aims to evaluate the association between HbA1c levels and gastric emptying using preoperative bedside gastric ultrasonography. Adult patients scheduled for elective surgery under general anesthesia will undergo gastric ultrasound examination after standard fasting. Gastric antral cross-sectional area and estimated gastric volume will be assessed and compared according to HbA1c levels. The findings of this study may help improve preoperative risk stratification for aspiration and support individualized anesthetic management in patients with impaired glycemic control.

Detailed description

This prospective observational study is designed to evaluate the relationship between hemoglobin A1c (HbA1c) levels and gastric emptying in adult surgical patients using bedside gastric ultrasonography.

Adult patients aged 18 to 70 years, scheduled for elective surgery under general anesthesia, will be enrolled. After standard preoperative fasting according to current guidelines, all participants will undergo a preoperative gastric ultrasound examination performed by a trained anesthesiologist. The gastric antrum will be assessed in standardized positions, and the antral cross-sectional area will be measured. Estimated gastric volume will be calculated using validated ultrasound-based formulas.

HbA1c levels will be obtained from preoperative laboratory records, and patients will be analyzed according to their HbA1c values. Gastric ultrasound findings, including antral cross-sectional area and estimated gastric volume, will be compared across different HbA1c levels.

Demographic data, anthropometric measurements including body mass index and waist circumference, fasting duration, and relevant clinical characteristics will also be recorded. The primary objective is to assess the association between HbA1c levels and gastric emptying parameters. Secondary analyses will explore potential factors associated with delayed gastric emptying.

The results of this study may contribute to improved preoperative risk assessment for pulmonary aspiration and support individualized anesthetic management in patients with impaired glycemic control.

Primary outcome measures

  • Gastric emptying assessed by gastric ultrasound [Time frame: The preoperative period,immediately before induction of anesthesia]

Eligibility criteria

Inclusion criteria

Adults aged 18 to 70 years. ASA physical status I-III. Scheduled for elective surgery under general anesthesia. Ability to provide written informed consent.

Exclusion criteria

Scheduled for emergency surgery. Refusal or inability to provide informed consent. Pregnancy. Age <18 years or >70 years. History of gastric surgery. Neuromuscular disease. Current use of opioid or anticholinergic medications.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Kutahya Health Science University Training and Research Hospital — Kütahya

Identifiers

NCT: NCT07375680 · KHSU-HbA1c-GastricUS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗