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NCT Number: NCT04181814

Gastric Ultrasound for Preoperative Assessment of Gastric Content in Diabetic Patients

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.

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Key information

Conditions

Aspiration Pneumonia Gastric Volume Infections Lung Diseases Pneumonia Pneumonia, Aspiration Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages >18 years old
  • Diabetes (I or II)
  • Following American Society of Anesthesiologists (ASA) fasting guidelines before surgery
  • Undergoing general anesthesia

Exclusion criteria

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

Treatment and study plan

Ultrasound

Device

Use ultrasound to assess gastric contents in diabetic patients before anesthesia

Primary outcomes

  1. Gastric contents

    Time frame: before anesthesia

    using ultrasound to evaluate antral cross-sectional area

  2. Risk factors

    Time frame: before anesthesia

    by analysisng full stomach of patients to find risk factors

Secondary outcomes

  1. Perlas grading scale

    Time frame: before anesthesia

    This 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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2019
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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