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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05732545
Other study ID # 2021-0899
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date November 1, 2022

Study information

Verified date February 2023
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, relevant contents of the enteral nutrition nursing programs for severe patients with abdominal pressure were systematically searched, and quality evaluation was carried out based on existing evidence. Based on evidence-based evidence, an enteral nutrition nursing program for patients with abdominal pressure was constructed, to improve the feed tolerance of patients with abdominal pressure, increase nutritional compliance rate, and improve patient prognosis.


Description:

Background: Enteral nutrition is the preferred method of artificial nutrition for critically ill patients. Early enteral nutrition within 24 to 48 hours after admission can maintain intestinal mucosal barrier function, increase local blood flow, reduce bacterial migration, and reduce the incidence of intestinal infections. Increased abdominal pressure is considered to be an independent risk factor for feeding intolerance in severe patients. Patients with abdominal pressure are prone to complications such as diarrhea, abdominal distension, vomiting, and even aspiration, which forces the suspension or suspension of enteral nutrition and leads to insufficient nutritional intake in patients. At present, there is evidence that regulating enteral nutrition through monitoring intra-abdominal pressure can effectively reduce the incidence of feeding intolerance in patients. Domestic and foreign scholars have formulated nutrition management programs for patients with intra-abdominal pressure from different aspects, such as monitoring and grading of intra-abdominal pressure, evaluation and management of tolerance, and prevention of complications. However, The standardized enteral nutrition feeding program oriented by the monitoring of intra-abdominal pressure has not yet formed a unified standard. Objective: This study conducted a quality evaluation based on existing evidence, adopted evidence-based research methods to establish an enteral nutrition program for patients with abdominal hypertension oriented by abdominal pressure, and aimed to improve the feeding tolerance of patients with abdominal hypertension, improve the nutritional compliance rate and improve the prognosis of patients through the implementation of evidence-based practice programs.


Recruitment information / eligibility

Status Completed
Enrollment 218
Est. completion date November 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 1. Inclusion Criteria 1. 12mmHg= intraperitoneal pressure =20mmHg (1mmHg=0.133kPa) 2. =18 years of age 3. Consistent with the indications of early enteral nutrition - Patients with nutritional risk, gastrointestinal function, or partial gastrointestinal function and unable to eat through the mouth - Stable hemodynamics (MAP > 65mmHg, blood lactic acid < 4mmol/L, and vasoactive drugs in the process of reduction or withdrawal) 4. Patients or their family members sign the informed consent 2. Exclusion Criteria 1. Pregnant or lactating female patients 2. Patients with recent abdominal surgery 3. Patients with a large number of abdominal effusions; 4. There are contraindications to enteral nutrition - Uncontrolled shock - Uncontrolled hypoxemia and acidosis - Uncontrolled upper gastrointestinal bleeding - GRV > 500mL/ 6h - Intestinal ischemia - Intestinal obstruction - Abdominal space syndrome (ACS) - High fistula without distal feeding

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
enteral nutrition program for patients with abdominal hypertension guided by abdominal pressure
There are 4 aspects of intra-abdominal pressure monitoring, source control and treatment for the etiology of increased abdominal pressure, enteral nutrition program, enteral nutrition tolerance evaluation and treatment

Locations

Country Name City State
China Feng Xiuqin Hangzhou

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of feeding intolerance Incidence of feeding intolerance: refers to the frequency of new cases of feeding intolerance within 7 days after the initiation of enteral nutrition. 7 days
Secondary The standard rate of feeding Enteral nutrition feeding standard rate (%)=(actual feeding quantity ÷ target feeding quantity)×100% 7 days
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