Ultrasound Assessment of Gastric Content and Volume

March 21, 2017 updated by: Jose Alejandro Valencia, Fundación Santa Fe de Bogota

Ultrasound Assessment of Gastric Content and Volume After Complete Fasting in Patients Undergoing Surgery at Two University Hospitals: A Multicentric Study

Anesthesiologists try to avoid complications with significant peri -operative morbidity and mortality such as bronchoaspiration in patients requiring a surgical procedure under anesthesia. Currently, this is achieved based on experts recommendations from the American Society of Anesthesiologists. However, there are tools like ultrasound that allow assessment of gastric content and volume. This tool allows to individualize each patient and base the decisions objectively. The investigators will assess gastric content and volume by ultrasound in patients who have fasted and require surgery at two University Hospitals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogota, Colombia
        • Hospital Universitario San Ignacio
      • Bogota, Colombia
        • Hospital Universitario Fundacion SantaFe de Bogota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Men and women 18 years or older requiring surgery with complete preoperative fasting (more than 8 hours but less than 14), ASA I-III.

Description

Inclusion Criteria:

  • Adults ≥ 18 years
  • perioperative fasting time between 8 and 14 hours
  • American Society of Anesthesiologists status I, II, III
  • Scheduled surgery

Exclusion Criteria:

  • Abdominal pathology surgical emergency
  • Unable to adopt right lateral decubitus position
  • Altered gastrointestinal tract anatomy excluding hiatal hernia
  • Body mass index greater than 40
  • Patients on enteral nutrition probe or with nasogastric probe
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric content
Time Frame: June to December
Ultrasound assessment of gastric content (empty, fluids, or solid) of patients undergoing surgery after complete fasting (more than 8 hours)
June to December
Gastric volume
Time Frame: June to December
Ultrasound assessment of gastric volume (in milliliters) of patients undergoing surgery after complete fasting (more than 8 hours)
June to December

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of gastric content and volume with special conditions as assessed by Anova or Kruskal as appropriate
Time Frame: June to December
To identify the association between gastric content and volume with conditions such as diabetes, obesity, hiatal hernia, among others.
June to December
Association with fasting time
Time Frame: June to December
To identify the association between gastric content and volume and preoperative fasting time.
June to December

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Santa Fe de Bogota

Collaborators

Hospital Universitario San Ignacio

Investigators

  • Principal Investigator: Jose A Valencia, MD, Fundacion Santa Fe de Bogota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (ESTIMATE)

June 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CCEI-5325-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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