The Effect of Early Enteral Nutrition Feeding Process Assisted by Gastrointestinal Ultrasonography

NCT05379582 | Completed

• 1 other identifier: 2022-050-02
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

In critical ill patients, feeding protocol is one of the important factor which determines the successful implementation of enteral nutrition（EN）. Acute gastrointestinal injury(AGI) affects feeding tolerance, which greatly determines the successful implementation of feeding protocol. In our previously study, we found that transabdominal intestinal sonography is helpful to diagnosis AGI. Thus in this study ,we apply transabdominal gastrointestinal sonography to feeding protocol, to assess the feasibility of gastrointestinal sonography assisted enteral nutrition and its impact on critical ill patients.

Conditions

Acute Gastrointestinal Injury; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Target-reaching rate through enteral route

  percentage of participants who reach target calorie through enteral route

  Within first week

Secondary Outcomes (13)

• The incidence of feeding intolerance

  Within first week

• The application of parenteral nutrition

  Within first week

• The application of prokinetic drugs

  Within first week

• The ues of vasoactive drugs

  Within first week

• Mechanical ventilation

  Within first week

Study Arms (2)

control group

NO INTERVENTION

Implement nutrition therapy according to existing feeding procedures

intervention group

EXPERIMENTAL

Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound

Other: Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound

Interventions

Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound OTHER

Once the critical ill patients is stable, enteral nutrition was initiated following a procedure assisted by gastrointestinal ultrasound.

intervention group

Eligibility Criteria

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

You may qualify if:

• The age is not less than 18 years
• within 24 hours after entering ICU
• Acute Physiology and Chronic Health Evaluation II (APACHE II) score \> 8
• the estimated length of stay in ICU is more than 3 days
• informed consent

You may not qualify if:

• The normal anatomy of stomach, small intestine or the right colon was significantly changed (Gastrectomy, esophagectomy, pancreaticoduodenectomy, gastrointestinal bypass surgery, the presence of short bowel syndrome,etc.)
• Uncontrolled gastrointestinal bleeding
• Uncontrolled intestinal obstruction
• Uncontrolled mesenteric vascular disease
• Pregnancy
• breastfeeding
• Received enteral nutrition or parenteral nutrition within 24 hours prior to ICU admission
• Predict death within 48 hours after ICU admission
• Enrolled in this study before.

Sponsors & Collaborators

• Chinese Medical Association: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• WenKui Yu, Professor

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 18, 2022
• Study Start: July 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CN (1)