- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07352202
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34000
- Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Investigators
- Principal Investigator: Berfin Gizem G Özelsel, MD, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-395
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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