NCT07352202

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 11, 2026

Last Update Submit

January 18, 2026

Conditions

Keywords

gastric ultrasoundıntensive care unitgastric residual volume

Outcome Measures

Primary Outcomes (1)

  • Change in Gastric Volume Estimated by Ultrasound

    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

Study Arms (3)

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)

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)

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)

Interventions

Enteral nutrition administered according to routine clinical practice without protocol-driven assignment or modification.

Specialized Enteral NutritionStandard Enteral NutritionWater Administration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital

Istanbul, Istanbul, 34000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Berfin Gizem G Özelsel, MD

    Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Berfin Gizem G Ozelsel, MD

CONTACT

Şule Altuncu, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2026

First Posted

January 20, 2026

Study Start

October 22, 2025

Primary Completion

April 22, 2026

Study Completion

April 22, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations