Ultrasound Assessment of Gastric Emptying in Mechanically Ventilated ICU Patients (GASTRIC-USG)

Evaluation of Gastric Emptying and Residual Volume Using Ultrasound in Mechanically Ventilated Intensive Care Patients Receiving Different Enteral Nutrition Solutions

This prospective observational study aims to evaluate dynamic changes in gastric volume and gastric emptying time using bedside gastric ultrasound in mechanically ventilated intensive care unit patients. The study compares gastric emptying patterns among patients receiving different types of enteral nutrition solutions as part of routine clinical care.

Study Overview

Status

Completed

Conditions

Detailed Description

This prospective observational study is designed to evaluate gastric emptying and changes in gastric volume using bedside gastric ultrasound in mechanically ventilated intensive care unit patients. Ultrasound examinations will be performed at predefined time points to assess gastric residual volume and gastric emptying patterns.

Patients receiving different types of enteral nutrition solutions as part of routine clinical care will be evaluated and compared. Gastric measurements will be obtained using standardized ultrasound techniques by trained clinicians.

The study aims to identify differences in gastric emptying dynamics associated with various enteral nutrition formulations and to assess the feasibility of bedside ultrasound as a non-invasive tool for monitoring gastric function in critically ill patients.

Study Type

Observational

Enrollment (Actual)

60

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

    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34000
        • Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients aged 18 years and older who are mechanically ventilated and admitted to the intensive care unit. Eligible patients are those receiving enteral nutrition via a nasogastric tube as part of routine clinical care and who are hemodynamically stable. Patients will be observed prospectively without any protocol-driven intervention.

Description

Inclusion Criteria:

  • Age 18 years or older
  • Mechanically ventilated patients admitted to the intensive care unit
  • Presence of a nasogastric tube
  • Hemodynamically stable patients receiving enteral nutrition as part of routine clinical care

Exclusion Criteria:

  • Recent abdominal surgery within the first 24 hours
  • Major abdominal trauma or burns
  • Significant ascites
  • Inadequate ultrasound window (e.g., severe meteorism)
  • Hemodynamic instability
  • Contraindication to enteral nutrition

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard Enteral Nutrition
Mechanically ventilated intensive care unit patients receiving standard enteral nutrition as part of routine clinical care.
Enteral nutrition administered according to routine clinical practice without protocol-driven assignment or modification.
Specialized Enteral Nutrition
Mechanically ventilated intensive care unit patients receiving specialized enteral nutrition formulations according to routine clinical practice.
Enteral nutrition administered according to routine clinical practice without protocol-driven assignment or modification.
Water Administration
Mechanically ventilated intensive care unit patients receiving water administration via nasogastric tube as part of routine care.
Enteral nutrition administered according to routine clinical practice without protocol-driven assignment or modification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gastric Volume Estimated by Ultrasound
Time Frame: Baseline and up to 60 minutes after enteral feeding
Dynamic changes in gastric volume estimated using ultrasound-derived antral cross-sectional area measurements at predefined time points before and after enteral feeding.
Baseline and up to 60 minutes after enteral feeding

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Berfin Gizem G Özelsel, MD, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

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 (Actual)

October 22, 2025

Primary Completion (Actual)

April 22, 2026

Study Completion (Actual)

April 22, 2026

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional data protection policies and the inclusion of critically ill patients. Data will be analyzed and reported in an aggregated and anonymized manner.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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