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Application of Enteral Nutrition Program in Patients With Intra-abdominal Hypertension Oriented by Intra-abdominal Pressure

Primary Purpose

Intra-Abdominal Hypertension

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
enteral nutrition program for patients with abdominal hypertension guided by abdominal pressure
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intra-Abdominal Hypertension focused on measuring Intra-Abdominal Hypertention, Enteral Nutrition, Feeding Intolerance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria 12mmHg≤ intraperitoneal pressure ≤20mmHg (1mmHg=0.133kPa) ≥18 years of age 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) Patients or their family members sign the informed consent Exclusion Criteria Pregnant or lactating female patients Patients with recent abdominal surgery Patients with a large number of abdominal effusions; 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

Sites / Locations

  • Feng Xiuqin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

enteral nutrition program by intra-abdominal pressure

Routine nursing measures

Arm Description

enteral nutrition program for patients with intra-abdominal hypertension guided by intra-abdominal pressure

Routine nursing measures

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The standard rate of feeding
Enteral nutrition feeding standard rate (%)=(actual feeding quantity ÷ target feeding quantity)×100%

Full Information

First Posted
February 8, 2023
Last Updated
February 22, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05732545
Brief Title
Application of Enteral Nutrition Program in Patients With Intra-abdominal Hypertension Oriented by Intra-abdominal Pressure
Official Title
Application of Enteral Nutrition Program in Patients With Intra-abdominal Hypertension Oriented by Intra-abdominal Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra-Abdominal Hypertension
Keywords
Intra-Abdominal Hypertention, Enteral Nutrition, Feeding Intolerance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
enteral nutrition program by intra-abdominal pressure
Arm Type
Experimental
Arm Description
enteral nutrition program for patients with intra-abdominal hypertension guided by intra-abdominal pressure
Arm Title
Routine nursing measures
Arm Type
No Intervention
Arm Description
Routine nursing measures
Intervention Type
Behavioral
Intervention Name(s)
enteral nutrition program for patients with abdominal hypertension guided by abdominal pressure
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of feeding intolerance
Description
Incidence of feeding intolerance: refers to the frequency of new cases of feeding intolerance within 7 days after the initiation of enteral nutrition.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
The standard rate of feeding
Description
Enteral nutrition feeding standard rate (%)=(actual feeding quantity ÷ target feeding quantity)×100%
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 12mmHg≤ intraperitoneal pressure ≤20mmHg (1mmHg=0.133kPa) ≥18 years of age 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) Patients or their family members sign the informed consent Exclusion Criteria Pregnant or lactating female patients Patients with recent abdominal surgery Patients with a large number of abdominal effusions; 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
Facility Information:
Facility Name
Feng Xiuqin
City
Hangzhou
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Application of Enteral Nutrition Program in Patients With Intra-abdominal Hypertension Oriented by Intra-abdominal Pressure

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