Reaching a Caloric Goal Using a Gastric Sonar Versus Aspiration of Gastric Contents in Critically Ill Patients Receiving Nasogastric Enteral Nutrition

Reaching a Caloric Goal Using a Gastric Sonar Versus Aspiration of Gastric Contents in Critically Ill Patients Receiving Nasogastric Enteral Nutrition - Randomized Controlled Trial

Enteral nutrition intolerance, manifested in delayed gastric emptying and high gastric residual, is a common problem in critically ill patients in intensive care, with adverse consequences on patients' outcomes. A decrease in the levels of the ghrelin hormone in these patients may contribute to this problem. The gastric residual test (GRV) is used to assess enteral absorption and gastric motility, but the traditional methods can lead to inaccuracy and waste of resources. In recent years, the use of ultrasound (PoCUS) to assess GRV has developed, but its effect on the rate of reaching the caloric goal has not yet been evaluated.

Study Overview

• Status: Recruiting
• Conditions: Enteral Nutrition Intolerance in Critically Ill Patients
• Intervention / Treatment: Diagnostic test: Ultrasound assessment

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel
    • Recruiting
    • Meir Medical Center
    • Contact: Sara Dichtwald, Dr.; Phone Number: 1 972-9-7472133; Email: sara.dichtwald@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Adult intensive care patients who recieve enteral nutrition via nasogastric tube -

Exclusion Criteria: 1. Pregnant patient 2. History of bariatric or other gastric surgery 3. Post-operative patients with sub-costal incision 4. Diaphragmatic hernia 5. Patients who recieve parenteral nutrition 6. Technically difficult US exam

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound group; Assessment of gastric residual volume via US	Diagnostic test: Ultrasound assessment; Ultrasound assessment of gastric residual volume
No Intervention: Aspiration group; assessment of gastric residual volume via aspiration of gastric content

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reaching the daily caloric goal	To compare the daily caloric goal via gastric residual volume assessment with ultrasound vs. gastric aspiration	3 days

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 0177-24-MMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No