Gastric Ultrasound for Preoperative Assessment of Gastric Content in Diabetic Patients

Aspiration Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04181814
• Other study ID #: 2019-319
• Status: Completed
• Start date: November 15, 2019
• Est. completion date: February 2, 2020

Study information

• Verified date: November 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Gastric Volume
• Pneumonia
• Pneumonia, Aspiration

Intervention

Device:
• Ultrasound
Use ultrasound to assess gastric contents in diabetic patients before anesthesia

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University Medical College	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric contents	using ultrasound to evaluate antral cross-sectional area	before anesthesia
Primary	Risk factors	by analysisng full stomach of patients to find risk factors	before anesthesia
Secondary	Perlas grading scale	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.	before anesthesia