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Ventilator-Associated EventsNCT07796724

Effectiveness of an Evidence-Based Respiratory and Renal Care Training With Case-Based Discussion on Nurses' Clinical Reasoning, Knowledge & Practice, Nurse-Physician Collaboration and Mechanically Ventilated Patient Outcomes in a Tertiary-Level ICU in Bangladesh

A study testing evidence-based respiratory and renal care training with case-based discussion in people with Ventilator-Associated Events and Acute Kidney Injury, run by Hiroshima University at 1 site in Bangladesh.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study will evaluate the effectiveness of an evidence-based respiratory and renal care training program combined with case-based discussion on nurses' clinical reasoning, knowledge \& practice, nurse-physician collaboration, as well as selected clinical outcomes among mechanically ventilated patients in a… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
evidence-based respiratory and renal care training with case-based discussion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteBangladesh
Study dates
Sep 2026to Dec 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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For nurses:
  • Registered nurses employed in the ICU at the time of enrollment
  • Involved in direct patient care
  • Willing to participate and provide informed written consent
  • For Patients:
  • Age ≥18 years
  • Patients receive mechanical ventilation for at least ≥ 48 hours
  • Legal guardian of the patients who will provide informed written consent

Who cannot join

  • For nurses:
  • Nurses on long-term leave and study leave during the intervention period
  • Nurses working exclusively in administrative or managerial roles
  • Nurses who did not complete the pre-test assessment
  • For Patients:
  • Patients mechanically ventilated for less than 48 hours.
Show all 9Show fewer
  • Patients who have already developed VAE or VAP at ICU admission
  • Patients with end-stage renal disease on chronic dialysis prior to ICU admission
  • Readmissions to ICU during the same hospital stay

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mina AKTER, Doctoral Student contact

+8801749211811, +81-0709094627

minajack417@gmail.com

Dr. Subrata Kumar Mondal, MBBS, MCPS, DA, FCPS contact

+88-01715437240

subrata326@yahoo.com

Bangladesh1 site
  • Dhaka Medical College & Hospital

    Dhaka, Dhaka Division, 1000

Other trials in Bangladesh

About this study

This study will evaluate the effectiveness of an evidence-based respiratory and renal care training program combined with case-based discussion on nurses' clinical reasoning, knowledge \& practice, nurse-physician collaboration, as well as selected clinical outcomes among mechanically ventilated patients in a tertiary-level ICU in Bangladesh.

The intervention will provide structured education and practical training to ICU nurses on evidence-based respiratory and renal care for mechanically ventilated patients. Case-based discussions will be conducted to promote clinical reasoning, evidence-based decision-making, and nurse-physician collaboration during daily ICU rounds.

Read more

Nurses' outcomes will be assessed before and after the intervention, focusing on clinical reasoning, knowledge, practice, and nurse-physician collaboration.

Patient outcomes will be assessed using historical pre-intervention data and post-intervention data among eligible mechanically ventilated ICU patients, focusing on ventilator-associated events (VAE), ventilator-associated pneumonia (VAP), Acute Kidney Injury (AKI), duration of mechanical ventilation, ICU length of stay, and ICU mortality.

The study is intended to determine whether evidence-based respiratory and renal care training with case-based discussion can improve ICU nurses' clinical reasoning, knowledge, practice, nurse-physician collaboration and contribute to improved outcomes among mechanically ventilated patients.

Read the detailed description

Background and Rationale:

Critically ill patients requiring mechanical ventilation are at high risk of complications related to respiratory and renal dysfunction, including ventilator-associated events (VAE), ventilator-associated pneumonia (VAP), acute kidney injury (AKI), prolonged mechanical ventilation, prolonged intensive care unit (ICU) stay, and death. Prevention, early recognition, and appropriate management of these complications require ICU nurses to possess adequate knowledge, clinical reasoning ability, practical skills, and effective communication and collaboration with physicians and other members of the ICU team.

In resource-limited settings, including Bangladesh, gaps in ICU staffing, continuing professional education, standardized clinical practices, and multidisciplinary communication may affect the quality and safety of care provided to mechanically ventilated patients. Evidence-based training that combines theoretical education with practical application and case-based clinical discussion may improve nurses' ability to recognize patient deterioration, interpret clinical findings, apply evidence-based interventions, and communicate effectively with physicians and other ICU professionals.

This study will evaluate an evidence-based respiratory and renal care training program combined with structured case-based discussion for ICU nurses in a tertiary-level ICU in Bangladesh. The intervention is designed to strengthen nurses' clinical reasoning, knowledge, clinical practice, and nurse-physician collaboration in the care of mechanically ventilated patients.

The study will also examine whether improvements in nursing competency and collaborative clinical decision-making are associated with improved patient outcomes.

Being tested
evidence-based respiratory and renal care training with case-based discussion
Keywords
VAE
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • evidence-based respiratory and renal care training with case-based discussionBehavioural

    The intervention will be provided over 2 months period. The evidence-based respiratory and renal care training will address respiratory assessment and monitoring, oxygen therapy and airway care, mechanical ventilation basics and ventilator care bundle practices, sedation, weaning and early mobilization, renal assessment and early detection of AKI based on kidney disease: Improving Global Outcomes (KDIGO) criteria, AKI prevention \& Renal Care Bundle, fluid balance and hemodynamic monitoring, Electrolyte \& Acid-Base Management.

    During daily ICU rounds, 10-15-minute bedside case discussions will be conducted for each mechanically ventilated ICU patients. An ICU consultant will facilitate the discussion using the ISBAR framework, involving the bedside nurse and other ICU team members. Each discussion will focus on the patient's current clinical condition, respiratory and renal assessment, interpretation of clinical findings, evidence-based care decisions, and appropriate management.

Study groups in NCT07796724
Study groupRoleWhat they receive
Historical Control group-Eligible mechanically ventilated ICU patients with usual standard careNo interventionEligible mechanically ventilated ICU patients received usual standard ICU care before implementation of the intervention. Historical patient data will be collected from medical records. ICU nurses will be assessed at baseline before receiving the intervention. No study intervention was administered during this phase.
Experimental-Eligible mechanically ventilated ICU patients with interventionExperimentalICU nurses will receive evidence-based respiratory and renal care training with case-based discussion to strengthen clinical reasoning, nurse-physician collaboration, and application of evidence-based ICU care. Eligible mechanically ventilated ICU patients will receive evidence based care after implementation of the intervention, and their outcomes will be measured.
Receives: Behavioral: evidence-based respiratory and renal care training with case-based discussion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Clinical Reasoning Competency Score

    Clinical reasoning will be measured among participating ICU nurses using the 22-item Clinical Reasoning Competency Scale developed by Bae et al. (2023). Each item is rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), with a total score ranging from 22 to 110. Higher scores indicate greater clinical reasoning competency. The total CRCS score will be assessed at baseline, midline, and endline. Baseline assessment will be conducted before the intervention, midline assessment will be conducted during the intervention period, and endline assessment will be conducted 2 months after completion of the intervention as a post-intervention follow-up. Changes in clinical reasoning competency across the three assessment time points will be evaluated.

    Measured: Baseline, midline, and 2-month post-intervention follow-up (endline)

  2. Incidence Rate of Ventilator-Associated Events

    The incidence rate of ventilator-associated events (VAE) among eligible mechanically ventilated ICU patients will be calculated as the number of VAE cases divided by the total number of ventilator days, multiplied by 1,000. VAE incidence will be compared between the pre-intervention and post-intervention periods.

    Measured: During the 2-month pre-intervention and the 2-month post-intervention observation period

Secondary outcomes (8)
  1. Change in Knowledge Score

    knowledge will be assessed among participating ICU nurses using a 50-item researcher-developed multiple-choice questionnaire. Each correct response will receive one point, resulting in a total score ranging from 0 to 50. Higher scores indicate greater knowledge. The total knowledge score will be assessed at baseline, midline, and endline. Changes in knowledge across the three assessment time points will be evaluated.

    Measured: Baseline, immediately post-intervention (midline), and 2-month post-intervention follow-up (endline)

  2. Change in Nurses Practice Score

    ICU nurses practice will be assessed among participating ICU nurses using a 40-item practice checklist covering evidence-based respiratory and renal care practices. The total practice score will be calculated according to the predefined scoring procedure, with higher scores indicating better adherence to recommended clinical practices. The practice score will be assessed at baseline, midline, and endline. Changes in nursing practice across the three assessment time points will be evaluated.

    Measured: Baseline, immediately post-intervention (midline), and 2-month post-intervention follow-up (endline)

  3. Change in Nurse-Physician Collaboration Score

    Nurse-physician collaboration will be assessed among participating ICU nurses using the Nurse-Physician Collaboration Scale developed by Ushiro (2009).Each item is rated on a 5-point Likert scale (1 = always to 5 = never), with a total score ranging from 27 to 135. Higher scores indicate poorer nurse-physician collaboration. Baseline assessment will be conducted before the intervention, midline assessment immediately after completion of the training intervention, and endline assessment 2 months after completion of the intervention as a post-intervention follow-up. Changes in nurse-physician collaboration across the three assessment time points will be evaluated.

    Measured: Baseline, immediately post-intervention (midline), and 2-month post-intervention follow-up (endline)

  4. Incidence Rate of Ventilator-Associated Pneumonia

    The incidence rate of ventilator-associated pneumonia (VAP) will be assessed among eligible mechanically ventilated ICU patients. VAP will be identified according to the predefined diagnostic criteria specified in the study protocol. The VAP incidence rate will be calculated as the number of VAP cases divided by the total number of ventilator days, multiplied by 1,000. The incidence rate will be compared between the pre-intervention and post-intervention periods.

    Measured: During the 2-month pre-intervention and the 2-month post-intervention observation period

  5. Incidence of Acute Kidney Injury

    The incidence of acute kidney injury (AKI) will be assessed among eligible ICU patients according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. AKI will be identified based on the predefined clinical and laboratory criteria specified in the study protocol. The proportion of patients who develop AKI during their ICU stay will be compared between the pre-intervention and post-intervention periods.

    Measured: During the 2-month pre-intervention and the 2-month post-intervention observation period

  6. ICU Mortality

    ICU mortality will be defined as death occurring during the ICU admission among eligible patients. The proportion of patients who die during their ICU stay will be compared between the pre-intervention and post-intervention periods.

    Measured: During the 2-month pre-intervention and the 2-month post-intervention observation period

  7. Duration of Mechanical Ventilation

    Duration of mechanical ventilation will be measured as the number of days from initiation of invasive mechanical ventilation until successful discontinuation of mechanical ventilation. The duration of mechanical ventilation will be compared between eligible patients in the pre-intervention and post-intervention periods.

    Measured: During the 2-month pre-intervention and the 2-month post-intervention observation period

  8. ICU Length of Stay

    ICU length of stay will be measured as the number of days from ICU admission until ICU discharge or death. ICU length of stay will be compared between eligible patients in the pre-intervention and post-intervention periods.

    Measured: During the 2-month pre-intervention and the 2-month post-intervention observation period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Model description
This is a sequential, two-arm, quasi-experimental study conducted in two phases. In the pre-intervention phase, baseline nurses' outcomes will be assessed, and historical data will be collected from eligible mechanically ventilated ICU patients who received usual care before implementation of the intervention. In the post-intervention phase, ICU nurses will receive the Training with Case-based Discussion Program, followed by assessment of nurses' outcomes. Patient outcomes will be assessed among eligible mechanically ventilated ICU patients receiving care after implementation of the intervention and compared with the historical pre-intervention patient group.
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07796724
Sponsor's protocol ID
BMRC/NREC/2025-2027/201
Status last verified
Aug 2026
First submitted
21 Aug 2026
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing evidence-based respiratory and renal care training with case-based discussion in people with Ventilator-Associated Events and Acute Kidney Injury, run by Hiroshima University at 1 site in Bangladesh.

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 8 inclusion and 9 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 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. 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 Mina AKTER, Doctoral Student (+8801749211811, +81-0709094627, minajack417@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Clinical Reasoning Competency Score (time frame: Baseline, midline, and 2-month post-intervention follow-up (endline)). 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 18 Sep 2026.

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