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Gastric Ultrasound for Preoperative Assessment of Gastric Content in Diabetic Patients

Bedside Gastric Ultrasound for Preoperative Assessment of Gastric Content in Diabetic Patients Following ASA Fasting Guidelines

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04181814
Enrollment
150
Registered
2019-11-29
Start date
2019-11-15
Completion date
2020-02-02
Last updated
2020-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspiration Pneumonia, Gastric Volume

Brief summary

ASA fasting guidelines are only applicable to healthy elective surgery patients. Measuring gastric volume now is not easy, and scintigraphy has remained the gold standard technique for many years. This prospective observational study aim to explore the gastric emptying of type 2 diabetic patients.

Detailed description

ASA fasting guidelines are only applicable to healthy elective surgery patients. Measuring gastric volume now is not easy, and scintigraphy has remained the gold standard technique for many years. Ultrasound has progressively emerged as a useful substitute due to its reduced cost and ease of performance. Using gastric ultrasound measure gastric antrum cross-sectional area to determine whether patients are empty stomach, help anesthesiologists in preoperative evaluation of diabetic patients with the risk of aspiration, so as to guide the anesthesiologist take effective interventions, this prospective observational study aim to explore the gastric emptying of type 2 diabetic patients.

Interventions

DEVICEUltrasound

Use ultrasound to assess gastric contents in diabetic patients before anesthesia

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Ages \>18 years old 2. Diabetes (I or II) 3. Following American Society of Anesthesiologists (ASA) fasting guidelines before surgery 4. Undergoing general anesthesia

Exclusion criteria

1. Pregnant 2. Gastric Intestinal Tract (GIT) diseases or surgeries affect gastric emptying 3. Diagnosed with liver dysfunction or renal insufficiency 4. Patients who are unable to cooperate or understand the process

Design outcomes

Primary

MeasureTime frameDescription
Gastric contentsbefore anesthesiausing ultrasound to evaluate antral cross-sectional area
Risk factorsbefore anesthesiaby analysisng full stomach of patients to find risk factors

Secondary

MeasureTime frameDescription
Perlas grading scalebefore anesthesiaThis is a 3-point grading system (grades 0, 1, and 2) based exclusively on qualitative sonographic assessment of the gastric antrum.If a patient's antrum appears empty in both supine and right lateral positions (grade 0), it is likely truly empty. If it appears only mildly distended in the right lateral decubitus position, but not in the supine position (grade 1), the patient likely has a very small volume of gastric fluid within the limits of what is known to be safe. An antrum that is distended in both supine and right lateral decubitus positions (grade 2) denotes a gastric fluid volume beyond the limits of what is considered safe.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026