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

May 19, 2026 updated by: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Standard Enteral Nutrition
Mechanically ventilated intensive care unit patients receiving standard enteral nutrition as part of routine clinical care.
Other: Enteral Nutrition (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.
Other: Enteral Nutrition (Routine Clinical Care)
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.
Other: Enteral Nutrition (Routine Clinical Care)
Enteral nutrition administered according to routine clinical practice without protocol-driven assignment or modification.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Berfin Gizem G Özelsel, MD, Şehit Prof. Dr. İlhan 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-395

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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