The Effect of Early Enteral Nutrition Feeding Process Assisted by Gastrointestinal Ultrasonography
- Conditions
- Acute Gastrointestinal InjuryCritical Illness
- Interventions
- Other: Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound
- Registration Number
- NCT05379582
- Lead Sponsor
- Chinese Medical Association
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention group Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound
- Primary Outcome Measures
Name Time Method Enteral nutrition support days within first seven days after enteral nutrition initiation Target-reaching rate through enteral route within first seven days after enteral nutrition initiation percentage of participants who reach target calorie through enteral route
The application rate of parenteral nutrition（PN） within first seven days after enteral nutrition initiation percentage of participants who needs parenteral nutrition
The application rate of prokinetic drugs within first seven days after enteral nutrition initiation percentage of participants who needs prokinetic drugs
mortality Day90 after enrollment
- Secondary Outcome Measures
Name Time Method The average dose of vasoactive drugs First week of the study Days of vasoactive drugs Through study completion, an average of 1 year Serum transferrin in milligram/liter Day14 after enteral nutrition initiation Serum prealbumin in milligram/liter 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 Day28 after enteral nutrition initiation 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 The mid-arm circumference in centimeter Through study completion, an average of 1 year. Acute Physiology and Chronic Health Evaluation score The first day after enrollment The value ranges from 0 to 71. A higher score means a worse outcome.
Sequential Organ Failure Assessment score The first day after enrollment. The value ranges from 0 to 24. A higher score means a worse outcome.
The strength of upper limb according to the Lovett muscle strength scale Through study completion, an average of 1 year. The value ranges from 0 to 5. A higher score means a better outcome.
The Medical Research Council sum score Through study completion, an average of 1 year The value ranges from 0 to 60. A higher score means a better outcome.
Trial Locations
- Locations (1)
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China