NCT05732545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

February 8, 2023

Last Update Submit

February 22, 2023

Conditions

Keywords

Intra-Abdominal HypertentionEnteral NutritionFeeding Intolerance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The standard rate of feeding

    7 days

Study Arms (2)

enteral nutrition program by intra-abdominal pressure

EXPERIMENTAL

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

Routine nursing measures

NO INTERVENTION

Routine nursing measures

Interventions

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

enteral nutrition program by intra-abdominal pressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mmHg≤ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feng Xiuqin

Hangzhou, 310000, China

Location

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 17, 2023

Study Start

January 1, 2022

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations