NCT04181814

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2020

Completed
Last Updated

March 6, 2020

Status Verified

November 1, 2019

Enrollment Period

2 months

First QC Date

November 27, 2019

Last Update Submit

March 4, 2020

Conditions

Aspiration PneumoniaGastric Volume

Outcome Measures

Primary Outcomes (2)

  • Gastric contents

    using ultrasound to evaluate antral cross-sectional area

    before anesthesia

  • Risk factors

    by analysisng full stomach of patients to find risk factors

    before anesthesia

Secondary Outcomes (1)

  • Perlas grading scale

    before anesthesia

Study Arms (1)

Diabetic patients

Diagnosed as diabetes

Device: Ultrasound

Interventions

UltrasoundDEVICE

Use ultrasound to assess gastric contents in diabetic patients before anesthesia

Diabetic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diabetic patients undergoing elective surgery and firmly following ASA fasting guidelines.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Pneumonia, Aspiration

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Min Yan, Doctor

    The Second Affiliated Hospital of Zhejiang University Medical College

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2019

First Posted

November 29, 2019

Study Start

November 15, 2019

Primary Completion

January 20, 2020

Study Completion

February 2, 2020

Last Updated

March 6, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)