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

NCT ID: NCT05379582

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-10-01

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.

Detailed Description

Patients meeting inclusion and exclusion criteria were randomly assigned to the intervention group and control group. During the first week of initiation of nutrition, enteral nutrition was conducted according to different procedures to observe the impact of different feeding procedures on clinical indicators

Conditions

Critical Illness; Acute Gastrointestinal Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

control group

Implement nutrition therapy according to existing feeding procedures

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention group

Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound

Group Type: EXPERIMENTAL

Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound

Intervention Type: OTHER

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

Interventions

Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Medical Association

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

WenKui Yu, Professor

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

2022-050-02

Identifier Type: -

Identifier Source: org_study_id