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

The Effect of Early Enteral Nutrition Feeding Process Assisted by Gastrointestinal Ultrasonography in Critically Ill Patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05379582
Enrollment
294
Registered
2022-05-18
Start date
2022-07-01
Completion date
2023-10-01
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Gastrointestinal Injury, Critical Illness

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

Interventions

OTHERImplement 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.

Sponsors

Chinese Medical Association
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Target-reaching rate through enteral routeWithin first weekpercentage of participants who reach target calorie through enteral route

Secondary

MeasureTime frame
Serum creatinineDay0,1,3,5,7
Platelet countDay0,1,3,5,7
The incidence of feeding intoleranceWithin first week
The application of parenteral nutritionWithin first week
The application of prokinetic drugsWithin first week
The ues of vasoactive drugsWithin first week
Mechanical ventilationWithin first week
Continuous renal replacementWithin first week
The CRP levelDay0/1/3/5/7
MortalityDay28、Day60、during hospitalization
ICU length of stayDuring ICU stay
Total bilirubinDay0,1,3,5,7
Length of hospital stayDuring hospital stay

Countries

China

Contacts

PRINCIPAL_INVESTIGATORWenKui Yu, Professor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026