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Trial record 42 of 43 for:    Recruiting, Not yet recruiting, Available Studies | "Gastroparesis"

Gastric Ultrasound for Estimation of the Aspiration Risk Study

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ClinicalTrials.gov Identifier: NCT03310528
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment
Respiratory Aspiration of Gastric Contents Behavioral: Interview questionnaire Procedure: Gastric ultrasound exam

Detailed Description:

Examine the utility of ultrasound examination of the stomach in estimating aspiration risk in patient populations whose aspiration risk is currently poorly understood. Evaluate the applicability of current pre-surgical fasting guidelines in the same patient populations whose aspiration risk is poorly understood.

Evaluate the residual gastric contents in patients presenting for upper GI endoscopy procedures who have adhered to pre-operative fasting guidelines. Evaluate the residual gastric contents in patients presenting for upper GI endoscopy procedures who have not adhered to pre-operative fasting guidelines. Only patients expected to have an oral-gastric tube placed during upper GI endoscopy procedure will be included. Both groups will be evaluated to learn if their residual gastric contents conform to currently-accepted standards for low aspiration risk.


Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Gastric Ultrasound for Estimation of the Aspiration Risk in High Aspiration-risk Surgical Patient Populations
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
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 questionnaire
Complete interview questionnaire regarding the composition and timing of their most recent food intake.

Procedure: Gastric ultrasound exam
Gastric ultrasound exam prior to upper GI endoscopy procedure.

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

Procedure: Gastric ultrasound exam
Gastric ultrasound exam prior to upper GI endoscopy procedure.

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

Procedure: Gastric ultrasound exam
Gastric ultrasound exam prior to upper GI endoscopy procedure.

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

Procedure: Gastric ultrasound exam
Gastric ultrasound exam prior to upper GI endoscopy procedure.




Primary Outcome Measures :
  1. Changes in gastric content volume between the four groups assessed by ultrasound examination [ Time Frame: Up to 12 hours ]
    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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Unwilling to undergo an ultrasound exam
  • Oral-gastric tube placement is not indicated
  • Oral-gastric tube placement is contraindicated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310528


Contacts
Contact: Judith M. Wishin, BSN 352-273-9096 jwishin@anest.ufl.edu
Contact: Cameron Smith, MD, PhD 352-246-0712 csmith@anest.ufl.edu

Locations
United States, Florida
United States, Florida UF Health Recruiting
Gainesville, Florida, United States, 32610-3003
Contact: Judith M Wishin, BSN    352-494-3165    jwishin@anest.ufl.edu   
Contact: Cameron Smith, MD    352-246-0712    csmith@anest.ufl.edu   
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Cameron Smith, MD, PhD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03310528     History of Changes
Other Study ID Numbers: IRB201602234
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Aspiration risk
GI Endoscopy
Fasting guidelines
Delayed gastric emptying

Additional relevant MeSH terms:
Respiratory Aspiration
Respiratory Aspiration of Gastric Contents
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Laryngopharyngeal Reflux
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases