Cold vs Warm Enteral Feeding and Gastric Emptying in Adult ICU Patients

NCT07415616 | Enrolling By Invitation

• 1 other identifier: 2024-TBEK 2025/08-17
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

In critically ill patients receiving enteral nutrition in the intensive care unit, the functional capacity of the gastrointestinal system can be significantly influenced by the mode of nutritional support. The temperature of enteral feeding may exert potential effects on gastric emptying, intestinal motility, and nutrient absorption. However, the existing literature on the impact of feeding temperature is limited, and randomized or cross-over controlled studies directly comparing warm and cold enteral feeding are scarce. This study aims to systematically evaluate the effects of enteral feeding temperature on feeding tolerance (vomiting and aspiration), gastric emptying rate (gastric residual volume), and the incidence of diarrhea, thereby providing evidence to inform clinical practice.

Conditions

Gastric Emptying; Enteral Nutrition (Food for Special Medical Purposes)

Outcome Measures

Primary Outcomes (1)

• Gastric volume measured by ultrasonography at 60, 90, 120, 180, 240, 360, and 480 minutes after administration of cold and warm enteral feeding.

  Baseline (0 minutes) and up to 480 minutes after enteral feeding

Study Arms (2)

Cold Enteral Feeding

ACTIVE COMPARATOR

Dietary Supplement: enteral nutrition

Warm Enteral feeding

ACTIVE COMPARATOR

Dietary Supplement: enteral nutrition

Interventions

enteral nutrition DIETARY_SUPPLEMENT

Cold enteral feeding (24-25 degree), warm enteral feeding (36-37 degree)

Cold Enteral Feeding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older
• Expected length of stay in the intensive care unit of at least 96 hours
• Patients receiving enteral nutrition via a nasogastric tube
• Absence of ileus or active gastrointestinal bleeding

You may not qualify if:

• Patients younger than 18 years of age
• Use of high-dose opioids known to affect gastrointestinal motility
• Patients receiving parenteral nutrition
• Known gastrointestinal diseases or a history of gastrointestinal surgery
• Patients with acute intracranial events will not be included in the study

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yuksek Ihtisas Research and Education Hospital

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate proffesor

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: September 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)