NCT06997614

Brief Summary

The EBN-based nutritional management protocol effectively enhances junior nurses' specialized critical thinking competency and improves patient nutritional outcomes and satisfaction, demonstrating its potential to optimize critical care quality. However, further validation through multicenter studies with larger cohorts, extended follow-up periods, and additional outcome measures is warranted.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

May 25, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

March 19, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

May 21, 2025

Last Update Submit

March 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improvement in Junior Nurses' Specialized Critical Thinking Competency

    Change in critical thinking scores measured by the Chinese Critical Thinking Disposition Inventory (CTDI-CV), a 70-item scale evaluating 7 dimensions (truth-seeking, open-mindedness, analyticity, systematicity, self-confidence, inquisitiveness, cognitive maturity) on a 6-point Likert scale. Higher scores indicate superior competency.

    Baseline: Before training (Day 0). Post-intervention: 3 months after protocol implementation.

Secondary Outcomes (3)

  • Serum Albumin Levels

    ICU admission (Day 0) and Day 14.

  • Serum Prealbumin Levels

    Day 0 and Day 14.

  • Patient Satisfaction

    Day 15.

Other Outcomes (5)

  • Incidence of Aspiration

    Daily monitoring until Day 14

  • Incidence of Diarrhea

    Daily monitoring until Day 14.

  • Incidence of Abdominal Distension

    Daily monitoring until Day 14.

  • +2 more other outcomes

Study Arms (2)

Conventional group

OTHER

The conventional group adhered to conventional nutritional management methods and training

Other: Conventional group

Evidence-based nursing group

OTHER

The study group implemented the EBN-based protocol alongside structured training

Other: evidence-based nursing group

Interventions

The conventional group adhered to conventional nutritional management methods and training

Conventional group

The study group implemented the EBN-based protocol alongside structured training

Evidence-based nursing group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of critical illness by attending physicians or higher-qualified specialists according to established critical care diagnostic standards
  • requirement for ICU admission with full access to standardized critical care and medical resources
  • preserved partial gastrointestinal function without severe intestinal obstruction or perforation confirmed by certified nutritionists or senior nurses, enabling potential enteral nutrition (EN) or combined EN-parenteral nutrition (PN) support.

You may not qualify if:

  • patients with severe cognitive impairment or psychiatric instability (e.g., advanced dementia, schizophrenia, status epilepticus) impairing capacity to engage in nutritional assessments or adhere to clinical protocols, which would jeopardize data collection reliability
  • terminal-stage conditions (malignancies, renal/hepatic failure) with life expectancy \< 7 days or exclusively receiving palliative care, leading to misalignment between their palliative nutritional goals and the study's therapeutic intervention objectives
  • congenital metabolic disorders (e.g., phenylketonuria) or short bowel syndrome requiring specialized nutritional protocols, which were incompatible with conventional critical care nutritional protocols and could compromise the generalizability of study findings
  • pregnancy/lactation due to unique nutritional demands and potential risks to fetal/infant development inherent in the study design, contravening established ethical standards
  • cases involving transfer, voluntary discharge, or withdrawal of consent that compromised data completeness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taizhou Hospital of Traditional Chinese Medicine

Taizhou, Jiangsu, 225300, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2025

First Posted

May 30, 2025

Study Start

May 25, 2025

Primary Completion

October 5, 2025

Study Completion

November 30, 2025

Last Updated

March 19, 2026

Record last verified: 2026-02

Locations