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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Completed
CT.gov ID
NCT05732545
Collaborator
(none)
218
1
2
10
21.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: enteral nutrition program for patients with abdominal hypertension guided by abdominal pressure
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
218 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Application of Enteral Nutrition Program in Patients With Intra-abdominal Hypertension Oriented by Intra-abdominal Pressure
Actual Study Start Date :
Jan 1, 2022
Actual Primary Completion Date :
Oct 1, 2022
Actual Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: enteral nutrition program by intra-abdominal pressure

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

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

No Intervention: Routine nursing measures

Routine nursing measures

Outcome Measures

Primary Outcome Measures

  1. Incidence of feeding intolerance [7 days]

    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

  1. The standard rate of feeding [7 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  1. Inclusion Criteria

  2. 12mmHg≤ intraperitoneal pressure ≤20mmHg (1mmHg=0.133kPa)

  3. ≥18 years of age

  4. 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)

  1. Patients or their family members sign the informed consent

  2. Exclusion Criteria

  3. Pregnant or lactating female patients

  4. Patients with recent abdominal surgery

  5. Patients with a large number of abdominal effusions;

  6. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Feng Xiuqin Hangzhou China 310000

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05732545
Other Study ID Numbers:
  • 2021-0899
First Posted:
Feb 17, 2023
Last Update Posted:
Feb 23, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2023