An interventional study of evidence-based respiratory and renal care training with case-based discussion in Ventilator-Associated Events, Acute Kidney Injury and Clinical Reasoning, sponsored by Hiroshima University. Not yet recruiting at 1 site in Bangladesh. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Hiroshima University · Not applicable, Interventional, and Prevention
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.
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.
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.
For nurses:
For Patients:
Exclusion Criteria:
For nurses:
For Patients:
Eligible 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.
ICU 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.
Behavioral: evidence-based respiratory and renal care training with case-based discussion
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.
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.
Time frame: Baseline, midline, and 2-month post-intervention follow-up (endline)
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.
Time frame: During the 2-month pre-intervention and the 2-month post-intervention observation period
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.
Time frame: Baseline, immediately post-intervention (midline), and 2-month post-intervention follow-up (endline)
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.
Time frame: Baseline, immediately post-intervention (midline), and 2-month post-intervention follow-up (endline)
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.
Time frame: Baseline, immediately post-intervention (midline), and 2-month post-intervention follow-up (endline)
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.
Time frame: During the 2-month pre-intervention and the 2-month post-intervention observation period
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.
Time frame: During the 2-month pre-intervention and the 2-month post-intervention observation period
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.
Time frame: During the 2-month pre-intervention and the 2-month post-intervention observation period
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.
Time frame: During the 2-month pre-intervention and the 2-month post-intervention observation period
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.
Time frame: During the 2-month pre-intervention and the 2-month post-intervention observation period
Plan to share: Undecided
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Hiroshima University