NCT07299799

Brief Summary

Quality of care is crucial for preventing adverse events such as infection in the intensive care units (ICUs). The most common ICU-acquired infections include pneumonia such as Ventilator Associated Pneumonia (VAP), Pressure Ulcer (PU), Medical Device Related Pressure Ulcer (MDRPU), and Central Line-Associated Bloodstream Infection (CLABSI). VAP, PU, and MDRPU are significant indicators of the quality of care, while CLABSI is a critical marker of healthcare quality in ICUs, as it is largely preventable through strict adherence to infection control protocols. VAP is a lung infection that occurs in patients receiving mechanical ventilation for more than 48 hours. A PU is defined as localized damage to the skin or underlying tissue caused solely by pressure, while MDRPUs may also result from friction or pressure from medical devices or other objects. CLABSI is a severe infection caused by improperly inserted or maintained central venous catheters, which underscores the need for stringent catheter management protocols.

Trial Health

67
Monitor

Trial Health Score

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

Enrollment
272

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
not yet recruiting

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

Study Progress79%
Feb 2026May 2026

First Submitted

Initial submission to the registry

November 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

November 23, 2025

Last Update Submit

February 10, 2026

Conditions

Keywords

evidence based practiceNurses competencyVentilator Associated PneumoniaPressure UlcerCentral Line Bloodstream InfectionMedical Device Related Pressure Ulcer

Outcome Measures

Primary Outcomes (2)

  • The nurse's skill related to the PU, MDRPU and CLABSI total score measured by the researcher-developed checklist

    1\. The nurse's skill and knowledge related to the PU, MDRPU and CLABSI checklist. Researcher developed checklist, 50 items with 0: not correct/did not do, 1: partially correct, 2: correct. Score range 0-114.

    6 month data collection and total time frame of this study 16 months

  • Incidence rates of PU, MDRPU and CLABSI.

    The incidence rate of PU was calculated as the number of newly developed pressure ulcers after hospitalization per 1000 person-days at risk. The incidence rate of MDRPU was calculated as the number of newly developed MDRPU cases per 1000 patients assessed. The incidence rate of CLABSI was calculated as the number of CLABSI cases per 1000 central line-days. Data will be collected: Patients' demographic data (age, sex, occupation etc.) Medical past and current history (diagnosis, treatment, medication, hospitalization). Reasons and date to be admitted to ICU. Treatment in ICU. Daily laboratory data taken in ICU. Daily biological data including vital signs. Results of patients' stay during ICU. Diagnosis of PU, MDRPU and CLABSI included of this list.

    2 month for data collection and total time frame 16 months.

Secondary Outcomes (7)

  • Nurses' knowledge, Attitude and Practice (KAP) related to the PU, MDRPU and CLABSI prevention measured by the researcher-developed scale based on Knowledge of EBP guidelines for the PU, MDRPU and CLABSI prevention scale

    Total data collection time 6 months within 16 months

  • Rate (number of patients) of each stage of PU and MDRPU

    Total 2 months

  • Micro-organism link to CLABSI

    2 months

  • Incidence and rate of VAP

    2 months

  • Mortality and morbidity rate of adverse events

    2 months

  • +2 more secondary outcomes

Other Outcomes (3)

  • APACHE II score

    2 months

  • SOFA score

    2 months

  • GCS score

    2 months

Study Arms (1)

Experimental: Trial 1: All Nurses in GICU; Trial 2: All patients admitted in the general GICU

EXPERIMENTAL

Nurses: All nurses who work at GICU of DMCH Patients: all patients who will admit at the assigned GICU during the study period of DMCH

Behavioral: Education with EBPBehavioral: This is a pre- and post- quasi-experimental study.

Interventions

Trial 1: Nurse's EBP training ( VAP, PU, MDRPU, CLABSI management), online lecture, 2 hours lecture and 3 hours skill training for nurses training. Trail 1 we use advanced equipment necessary for EBP implementation for VAP, PU, MDRPU and CLABSI management, and EBP-trained nurses implementation for all this management.

Experimental: Trial 1: All Nurses in GICU; Trial 2: All patients admitted in the general GICU

We will use advanced equipment and implement EBP (VAP, PU, MDRPU and CLABSI management) for patients by trained nurses and check the outcome of the patients. We will compare pre and post findings for this study.

Experimental: Trial 1: All Nurses in GICU; Trial 2: All patients admitted in the general GICU

Eligibility Criteria

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

You may qualify if:

  • Nurse
  • who is a registered nurse in Bangladesh.
  • who agrees to participate in this study and the EBP training.
  • who will stay at the ICU for 6 months. Patient
  • Irrespective of age and sex, participants must be at least 18 years old
  • Legal guardian of a patient consent to participation in the study

You may not qualify if:

  • Nurse
  • Who will not directly involve patient care in ICU. Patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dhaka Medical College Hospital

Dhaka, Dhaka Division, Bangladesh

Location

Hiroshima University

Hiroshima, Hiroshima City, 7348551, Japan

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-AssociatedPressure Ulcer

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Nahida Akhter, Ph. D Fellow

CONTACT

Moriyama Michiko, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Trial 1: A pre- and post- quasi-experimental study to evaluate the nurses competency (Skill, knowledge, practice and attitude). Trial 2: A pre- and post- quasi-experimental study to evaluate the outcomes of the patients in the ICU using study 1 Phase 1 data as historical data.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Ph.D Fellow, Graduate School of Biomedical and Health Sciences, Hiroshima University, Japan.

Study Record Dates

First Submitted

November 23, 2025

First Posted

December 23, 2025

Study Start

February 15, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

IPD will not be share due to personal confidentiality of the participants. When the data will be available and we will share the data according to the recommendations of the clinical trial registration and the requests of the journals.

Locations