Gastric Ultrasound for Preoperative Assessment of Gastric Content in Diabetic Patients

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Completed
CT.gov ID
NCT04181814
Collaborator
(none)
150
1
2.6
57.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ultrasound

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 Design

Study Type:
Observational
Actual Enrollment :
150 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Bedside Gastric Ultrasound for Preoperative Assessment of Gastric Content in Diabetic Patients Following ASA Fasting Guidelines
Actual Study Start Date :
Nov 15, 2019
Actual Primary Completion Date :
Jan 20, 2020
Actual Study Completion Date :
Feb 2, 2020

Arms and Interventions

Arm Intervention/Treatment
Diabetic patients

Diagnosed as diabetes

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

Outcome Measures

Primary Outcome Measures

  1. Gastric contents [before anesthesia]

    using ultrasound to evaluate antral cross-sectional area

  2. Risk factors [before anesthesia]

    by analysisng full stomach of patients to find risk factors

Secondary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Second Affiliated Hospital of Zhejiang University Medical College Hangzhou Zhejiang China 310000

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Chair: Min Yan, Doctor, The Second Affiliated Hospital of Zhejiang University Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04181814
Other Study ID Numbers:
  • 2019-319
First Posted:
Nov 29, 2019
Last Update Posted:
Mar 6, 2020
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 6, 2020