NCT03310528

Brief Summary

The purpose of this research study is to look at the effectiveness of current anesthesia guidelines regarding food and drink prior to surgery in patients who are likely to have food and drink remain in their stomach longer than might ordinarily be expected.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress98%
Mar 2018Jul 2026

First Submitted

Initial submission to the registry

October 4, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

March 27, 2018

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2026

Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

8.3 years

First QC Date

October 4, 2017

Last Update Submit

July 10, 2025

Conditions

Respiratory Aspiration of Gastric Contents

Keywords

Aspiration riskGI EndoscopyFasting guidelinesDelayed gastric emptying

Outcome Measures

Primary Outcomes (1)

  • Changes in gastric content volume between the four groups assessed by ultrasound examination

    Evaluate the residual gastric contents in patients presenting for upper GI endoscopy procedures to learn if their residual gastric contents conform to currently-accepted standards for low aspiration risk.

    Up to 12 hours

Study Arms (4)

Obeyed fasting guidelines

Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.

Behavioral: Interview questionnaireProcedure: Gastric ultrasound exam

Did not obey fasting guidelines

Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.

Behavioral: Interview questionnaireProcedure: Gastric ultrasound exam

Trauma - obeyed fasting guidelines

Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.

Behavioral: Interview questionnaireProcedure: Gastric ultrasound exam

Trauma - did not obey fasting guidelines

Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.

Behavioral: Interview questionnaireProcedure: Gastric ultrasound exam

Interventions

Interview questionnaireBEHAVIORAL

Complete interview questionnaire regarding the composition and timing of their most recent food intake.

Did not obey fasting guidelinesObeyed fasting guidelinesTrauma - did not obey fasting guidelinesTrauma - obeyed fasting guidelines
Gastric ultrasound examPROCEDURE

Gastric ultrasound exam prior to upper GI endoscopy procedure.

Did not obey fasting guidelinesObeyed fasting guidelinesTrauma - did not obey fasting guidelinesTrauma - obeyed fasting guidelines

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting for upper GI endoscopy and/or endoscopic retrograde cholangiopancreatogram (ERCP), expected to have an oral-gastric tube placed as part of scheduled procedure.

You may qualify if:

  • Presenting for upper GI endoscopy procedures or surgical repair of a trauma- related injury
  • Expected to have an oral-gastric tube placed as part of scheduled procedure
  • Willing to undergo an ultrasound exam
  • Patients ≥ 18 years of age

You may not qualify if:

  • Unwilling to undergo an ultrasound exam
  • Oral-gastric tube placement is not indicated
  • Oral-gastric tube placement is contraindicated
  • Pregnant patients and patients from defined vulnerable populations (ex. pediatric patients, mentally handicapped patients, prisoners, etc.)
  • Surgical trauma patients who are not expected to have an OG tube placed during surgery
  • Patients with history of gastric bypass surgery
  • Patients that are gastrostomy tube dependent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United States, Florida UF Health

Gainesville, Florida, 32610-3003, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration of Gastric ContentsGastroparesis

Condition Hierarchy (Ancestors)

Laryngopharyngeal RefluxGastroesophageal RefluxEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesRespiratory AspirationRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsStomach DiseasesParalysisNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Cameron Smith, MD, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 16, 2017

Study Start

March 27, 2018

Primary Completion (Estimated)

July 14, 2026

Study Completion (Estimated)

July 14, 2026

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)