Ventilator Acquired PneumoniaEBP in NursingNCT07299799
Evidence-Based Nursing to Reduce Adverse Events Regarding Ventilator Associated Pneumonia, Pressure Injuries and Central Line Bloodstream Infection in Intensive Care Unit in Bangladesh
A study testing Education with EBP and This is a pre- and post- quasi-experimental study. in people with Ventilator Acquired Pneumonia and Central Line Associated Blood Stream Infections (CLABSI), run by Hiroshima University at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventilator Acquired Pneumonia, Central Line Associated Blood Stream Infections (CLABSI), Pressure Ulcer (PU)
- What is being tested?
- Education with EBP and This is a pre- and post- quasi-experimental study.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Feb 2026to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Nurse
- Who will not directly involve patient care in ICU. Patient
- No exclusion criteria
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Bangladesh1 site
Dhaka Medical College Hospital
Dhaka, Dhaka Division
Nahida Akhter, PhD Fellow, +88-01925478065, nahida1789@gmail.com
Japan1 site
Hiroshima University
Hiroshima, Hiroshima City, 7348551
Moriyama Michiko, PhD, +81-82-257-5367, morimich@hiroshima-u.ac.jp
About this study
Official title: Evidence-Based Nursing to Reduce Adverse Events Regarding Ventilator Associated Pneumonia, Pressure Injuries and Central Line Bloodstream Infection in Intensive Care Unit: A Quasi-experimental Study in Bangladesh
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.
Read the detailed description
General Objective:
The objective of this study is to evaluate whether implementing EBP and changing nurses' competency (skill, knowledge, practice, and attitude) can reduce ICU adverse events such as VAP, PU, MDRPU, and CLABSI, and improve patient outcomes.
Specific Objectives:
- To identify insights on perceptions, barriers, and facilitators related to EBP implementation in the ICU setting.
- To evaluate the effect of EBP training on nurses' competency (skill, knowledge, practice, and attitude) regarding EBP for CLABSI, PU, and MDRPU in an ICU setting.
- To evaluate the effects of EBP on ICU patient incidence rates of VAP, CLABSI, PU, and MDRPU.
Hypothesis:
H1- Hypothesize that training on EBP and its implementation in ICU settings will improve nurses' competency (Skill, knowledge, practice and attitude).
H2- Hypothesize that implementation of EBP by trained ICU nurses will reduce adverse events-such as VAP, pressure ulcers, medical device-related PU, and CLABSIs-and improve overall patient outcomes.
These research consist of two studies:
- Evaluating the effect of EBP training on ICU nurses' competency (skill, knowledge, practice, and attitude) regarding EBP for CLABSI, PU, and MDRPU in an ICU setting. A pre- and post-quasi-experimental study will be conducted over a 16-month period, with a total data collection period of 6 months, to evaluate nurses' competency. The study consists of a recruitment period (1 month), nurses' baseline data collection (1 month), nurses' EBP training with midline data collection (2 months), and nurses' endline data collection during EBP implementation (2 months). Study nurses will receive EBP training and appropriate equipment for patient management. EBP education and training will be provided with necessary equipment, such as a closed suction catheter, an endotracheal tube, a suction device, and a mouth care brush. In this study, global standard equipment will be used to ensure patient safety.
- Evaluating the effect of EBP implementation on ICU patient incidence rates of VAP, CLABSI, PU, and MDRPU.
A pre- and post-quasi-experimental design with a non-equivalent control group (Study 1, Phase 1 data used as historical data) will be applied by comparing the rate of adverse events such as VAP, CLABSI, PU, and MDRPU before and after the EBP intervention (2-month baseline data and 2-month intervention data will be collected).
- Conditions
- Ventilator Acquired Pneumonia, Central Line Associated Blood Stream Infections (CLABSI), Pressure Ulcer (PU), Medical Device Related Pressure Ulcer (MDRPU)
- Being tested
- Education with EBP, This is a pre- and post- quasi-experimental study.
- Keywords
- evidence based practice, Nurses competency, Ventilator Associated Pneumonia, Pressure Ulcer, Central Line Bloodstream Infection, Medical Device Related Pressure Ulcer
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education with EBPBehavioural
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.
This is a pre- and post- quasi-experimental study.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Education with EBP; Behavioral: This is a pre- and post- quasi-experimental study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The nurse's skill related to the PU, MDRPU and CLABSI total score measured by the researcher-developed checklist
- 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.
Measured: 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.
Measured: 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
Nurses attitude, practice and knowledge related PU, MDPU and CLABSI related prevention scale.
The researcher makes an attitude, practice and knowledge related of EBP guideline for PU, MDPU and CLABSI question Total item 22 and validity was tested by ICU and PU specialized nurses in Japan.
Knowledge was assessed using multiple-choice questions, with one correct answer among four options. Each correct response was awarded a score of 1, and incorrect or "don't know" responses were scored 0.
Attitude and practice were measured using a Likert scale, with responses indicating the degree of agreement or frequency.
Measured: Total data collection time 6 months within 16 months
Rate (number of patients) of each stage of PU and MDRPU
After diagnosis of sore we measured stage of PU and MDRPU. Number of ICU patients developing PU and MDRPU categorized by stage (Stage I-IV). Unit of Measure: Number of patients per PU/MDRPU stage.
Measured: Total 2 months
Micro-organism link to CLABSI
After diagnosis of CLABSI then identify what kind organism relate to CLABSI. Type and frequency of microorganisms identified in laboratory-confirmed CLABSI cases. Unit of Measure: Number of cases per microorganism.
Measured: 2 months
Incidence and rate of VAP
Incidence rate of VAP per 1000 ventilator days. Unit of Measure: VAP cases per 1,000 ventilator days
Measured: 2 months
Mortality and morbidity rate of adverse events
Mortality and morbidity rate of ICU patients All-cause mortality among ICU patients during the study period. Unit of Measure: Percentage (%)。Occurrence of ICU-related adverse events (VAP, CLABSI, PU, MDRPU). Unit of Measure: Number of patients with adverse events.
Measured: 2 months
Average length of stay ICU patients
Average length of stay ICU patients. Mean length of stay in the intensive care unit for enrolled patients. Unit of Measure: Days (mean ± SD).
Measured: 2 months
Survival rate of ICU
Average survival rate of ICU. Data will be collected: Length of stay and survival rate. Proportion of enrolled patients alive at ICU discharge. Unit of Measure: Percentage (%) of patients surviving to ICU discharge.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start15 Feb 2026 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahida Akhter, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299799
- Sponsor's protocol ID
- BMRC/NREC/2025-2027/313
- Other IDs
- 65313072025, 24K02733
- Acronym
- EBP in Nursing
- Status last verified
- Feb 2026
- First submitted
- 23 Nov 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-Based Nursing to Reduce Adverse Events Regarding Ventilator Associated Pneumonia, Pressure Injuries and Central Line Bloodstream Infection in Intensive Care Unit: A Quasi-experimental Study in Bangladesh
- ClinicalTrials.gov ID
- NCT07299799
- Acronym / sponsor ID
- EBP in Nursing / BMRC/NREC/2025-2027/313
- Conditions
- Ventilator Acquired Pneumonia, Central Line Associated Blood Stream Infections (CLABSI), Pressure Ulcer (PU), Medical Device Related Pressure Ulcer (MDRPU)
- Keywords
- evidence based practice, Nurses competency, Ventilator Associated Pneumonia, Pressure Ulcer, Central Line Bloodstream Infection, Medical Device Related Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
General Objective:
The objective of this study is to evaluate whether implementing EBP and changing nurses' competency (skill, knowledge, practice, and attitude) can reduce ICU adverse events such as VAP, PU, MDRPU, and CLABSI, and improve patient outcomes.
Specific Objectives:
- To identify insights on perceptions, barriers, and facilitators related to EBP implementation in the ICU setting.
- To evaluate the effect of EBP training on nurses' competency (skill, knowledge, practice, and attitude) regarding EBP for CLABSI, PU, and MDRPU in an ICU setting.
- To evaluate the effects of EBP on ICU patient incidence rates of VAP, CLABSI, PU, and MDRPU.
Hypothesis:
H1- Hypothesize that training on EBP and its implementation in ICU settings will improve nurses' competency (Skill, knowledge, practice and attitude).
H2- Hypothesize that implementation of EBP by trained ICU nurses will reduce adverse events-such as VAP, pressure ulcers, medical device-related PU, and CLABSIs-and improve overall patient outcomes.
These research consist of two studies:
- Evaluating the effect of EBP training on ICU nurses' competency (skill, knowledge, practice, and attitude) regarding EBP for CLABSI, PU, and MDRPU in an ICU setting. A pre- and post-quasi-experimental study will be conducted over a 16-month period, with a total data collection period of 6 months, to evaluate nurses' competency. The study consists of a recruitment period (1 month), nurses' baseline data collection (1 month), nurses' EBP training with midline data collection (2 months), and nurses' endline data collection during EBP implementation (2 months). Study nurses will receive EBP training and appropriate equipment for patient management. EBP education and training will be provided with necessary equipment, such as a closed suction catheter, an endotracheal tube, a suction device, and a mouth care brush. In this study, global standard equipment will be used to ensure patient safety.
- Evaluating the effect of EBP implementation on ICU patient incidence rates of VAP, CLABSI, PU, and MDRPU.
A pre- and post-quasi-experimental design with a non-equivalent control group (Study 1, Phase 1 data used as historical data) will be applied by comparing the rate of adverse events such as VAP, CLABSI, PU, and MDRPU before and after the EBP intervention (2-month baseline data and 2-month intervention data will be collected).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Trial 1: All Nurses in GICU; Trial 2: All patients admitted in the general GICU | Experimental | Behavioral: Education with EBP, Behavioral: This is a pre- and post- quasi-experimental study.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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Nurse
- Who will not directly involve patient care in ICU. Patient
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education with EBPTrial 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. | Behavioural | Experimental: Trial 1: All Nurses in GICU; Trial 2: All patients admitted in the general GICU |
| This is a pre- and post- quasi-experimental study.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. | Behavioural | Experimental: Trial 1: All Nurses in GICU; Trial 2: All patients admitted in the general GICU |
Primary outcome
The nurse's skill related to the PU, MDRPU and CLABSI total score measured by the researcher-developed checklist
Time frame: 6 month data collection and total time frame of this study 16 months
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.
Incidence rates of PU, MDRPU and CLABSI.
Time frame: 2 month for data collection and total time frame 16 months.
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.
7 secondary outcomes
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
Time frame: Total data collection time 6 months within 16 months
Rate (number of patients) of each stage of PU and MDRPU
Time frame: Total 2 months
Micro-organism link to CLABSI
Time frame: 2 months
Incidence and rate of VAP
Time frame: 2 months
Mortality and morbidity rate of adverse events
Time frame: 2 months
Average length of stay ICU patients
Time frame: 2 months
Survival rate of ICU
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education with EBP and This is a pre- and post- quasi-experimental study. in people with Ventilator Acquired Pneumonia and Central Line Associated Blood Stream Infections (CLABSI), run by Hiroshima University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nahida Akhter, Ph. D Fellow (+8801925478065, nahida1789@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The nurse's skill related to the PU, MDRPU and CLABSI total score measured by the researcher-developed checklist (time frame: 6 month data collection and total time frame of this study 16 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.