Gastric Ultrasound for Preoperative Assessment of Gastric Content in Diabetic Patients

Completed

• Conditions: Aspiration Pneumonia; Gastric Volume
• Interventions: Device: Ultrasound

• Registration Number: NCT04181814
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2019-11
• Study Start: 2019-11-15
• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-11-27
• Study First Posted: 2019-11-29
• Primary Completion: 2020-01-20
• Study Completion: 2020-02-02
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic patients	Ultrasound	Diagnosed as diabetes

Primary Outcome Measures

Name	Time	Method
Risk factors	before anesthesia	by analysisng full stomach of patients to find risk factors
Gastric contents	before anesthesia	using ultrasound to evaluate antral cross-sectional area

Secondary Outcome Measures

Name	Time	Method
Perlas grading scale	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.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University Medical College; 🇨🇳 Hangzhou, Zhejiang, China