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RecruitingNCT07375680

HbA1c Levels and Gastric Emptying Assessed by Gastric Ultrasound

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
134 (estimated)
Sponsor
Kutahya Health Sciences University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Timeline

Start date
2026-02-15
Primary completion
2026-08-15
Completion
2026-09-01
First posted
2026-01-29
Last updated
2026-04-08

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07375680. Inclusion in this directory is not an endorsement.