NCT03184532

Brief Summary

To reduce the risk of perioperative pulmonary aspiration of gastric contents, oral intake of liquids or solids is not allowed for certain periods. Recently, the ultrasound (US) is used to evaluate the volume and the nature of the stomach content. In its latest recommendations, the American Society of Anesthesiologists (ASA) shortened the duration preoperative fasting. The aim of the study is to evaluate the efficacy of ASA recommendations in diabetic patients using ultrasound (US) scanning of the stomach (antrum).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

June 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

June 9, 2017

Last Update Submit

June 9, 2017

Conditions

Evaluation of ASA Fasting Recommendations in Diabetic Patients

Outcome Measures

Primary Outcomes (1)

  • gastric volume

    bedside test 5 minutes

Study Arms (2)

D

diabetic patients

Diagnostic Test: ultrasound

ND

non-diabetic patients

Diagnostic Test: ultrasound

Interventions

ultrasoundDIAGNOSTIC_TEST

ultrasound examination of pyloric antrum

DND

Eligibility Criteria

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

Patients scheduled for elective orthopedic procedures.

You may qualify if:

  • Patients scheduled for elective orthopedic procedures.

You may not qualify if:

  • Patients with BMI \> 35 kg.m-2, age \<18y, ASA physical state \>II, fasting more than 6hs, or with gastric diseases will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Mohamed Sayed Elahl, MD

CONTACT

00971501257051m.elahl@healthpoint.ae

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesia consultant

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 12, 2017

Study Start

July 1, 2017

Primary Completion

December 15, 2017

Study Completion

December 31, 2017

Last Updated

June 12, 2017

Record last verified: 2017-06