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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Acute Gastrointestinal Injury
• Intervention / Treatment: Other: Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound

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

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tao Gao, no; Phone Number: +86-025-83106666; Email: ggttt001@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Nanjing Drum Tower hospital
      • Contact: Tao Gao, no; Phone Number: 86-025-83106666; Email: ggttt001@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; Implement nutrition therapy according to existing feeding procedures
Experimental: intervention group; Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality		Day28 after enrollment
mortality		Day60 after enrollment
mortality		Day90 after enrollment
Enteral nutrition support days		within first seven days after enteral nutrition initiation
Target-reaching rate through enteral route	percentage of participants who reach target calorie through enteral route	within first seven days after enteral nutrition initiation
The application rate of parenteral nutrition（PN）	percentage of participants who needs parenteral nutrition	within first seven days after enteral nutrition initiation
The application rate of prokinetic drugs	percentage of participants who needs prokinetic drugs	within first seven days after enteral nutrition initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sequential Organ Failure Assessment score	The value ranges from 0 to 24. A higher score means a worse outcome.	The first day after enrollment.
Acute Physiology and Chronic Health Evaluation score	The value ranges from 0 to 71. A higher score means a worse outcome.	The first day after enrollment
The average dose of vasoactive drugs		First week of the study
Days of vasoactive drugs		Through study completion, an average of 1 year
Days of mechanical ventilation		Through study completion, an average of 1 year
Days of continuous renal replacement		Through study completion, an average of 1 year
Serum prealbumin in milligram/liter		Day7 after enteral nutrition initiation
Serum prealbumin in milligram/liter		Day14 after enteral nutrition initiation
Serum transferrin in milligram/liter		Day7 after enteral nutrition initiation
Serum transferrin in milligram/liter		Day14 after enteral nutrition initiation
The thickness of diaphragm under ultrasonography in centimeter		Day7 after enteral nutrition initiation
The thickness of diaphragm under ultrasonography in centimeter		Day14 after enteral nutrition initiation
The thickness of diaphragm under ultrasonography in centimeter		Day28 after enteral nutrition initiation
The thickness of quadriceps under ultrasonography in centimeter		Day7 after enteral nutrition initiation
The thickness of quadriceps under ultrasonography in centimeter		Day14 after enteral nutrition initiation
The thickness of quadriceps under ultrasonography in centimeter		Day28 after enteral nutrition initiation
The strength of upper limb according to the Lovett muscle strength scale	The value ranges from 0 to 5. A higher score means a better outcome.	Day7 after enteral nutrition initiation
The strength of upper limb according to the Lovett muscle strength scale	The value ranges from 0 to 5. A higher score means a better outcome.	Day14 after enteral nutrition initiation
The strength of upper limb according to the Lovett muscle strength scale	The value ranges from 0 to 5. A higher score means a better outcome.	Day28 after enteral nutrition initiation
The strength of upper limb according to the Lovett muscle strength scale	The value ranges from 0 to 5. A higher score means a better outcome.	Through study completion, an average of 1 year.
The mid-arm circumference in centimeter		Day7 after enteral nutrition initiation
The mid-arm circumference in centimeter		Day14 after enteral nutrition initiation
The mid-arm circumference in centimeter		Day28 after enteral nutrition initiation
The mid-arm circumference in centimeter		Through study completion, an average of 1 year.
The Medical Research Council sum score	The value ranges from 0 to 60. A higher score means a better outcome.	Day14 after enteral nutrition initiation
The Medical Research Council sum score	The value ranges from 0 to 60. A higher score means a better outcome.	Day28 after enteral nutrition initiation
The Medical Research Council sum score	The value ranges from 0 to 60. A higher score means a better outcome.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Chinese Medical Association
• Investigators: Principal Investigator: WenKui Yu, Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2022-050-02

Drug and device information, study documents

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