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NCT Number: NCT07796724

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

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.

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Key information

Conditions

Ventilator-Associated Events Acute Kidney Injury Clinical Reasoning Cross Infection Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Healthcare-Associated Pneumonia Iatrogenic Disease Infections Kidney Diseases Lung Diseases Male Urogenital Diseases Nurse-Physician Collaboration Nurses Knowledge & Practice Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Renal Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Urologic Diseases Ventilator-Associated Pneumonia (VAP)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dhaka Medical College & Hospital

Dhaka, Dhaka Division, 1000, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.
  • 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

Treatment and study plan

evidence-based respiratory and renal care training with case-based discussion

Behavioral

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.

Primary outcomes

  1. Change in Clinical Reasoning Competency Score

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

    Clinical reasoning will be measured among participating ICU nurses using the 22-item Clinical Reasoning Competency Scale (CRCS) 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.

  2. Incidence Rate of Ventilator-Associated Events

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

    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.

Secondary outcomes

  1. Change in Knowledge Score

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

    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.

  2. Change in Nurses Practice Score

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

    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.

  3. Change in Nurse-Physician Collaboration Score

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

    Nurse-physician collaboration will be assessed among participating ICU nurses using the Nurse-Physician Collaboration Scale (NPCS) developed by Ushiro (2009).Each item is rated on a 5-point Likert scale, with responses ranging from 1 to 5.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.

  4. Incidence Rate of Ventilator-Associated Pneumonia

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

    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.

  5. Incidence of Acute Kidney Injury

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

    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.

  6. ICU Mortality

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

    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.

  7. Duration of Mechanical Ventilation

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

    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.

  8. ICU Length of Stay

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+88-01715437240

Mina AKTER, Doctoral Student

CONTACT

[email protected]

+8801749211811, +81-0709094627

Sponsors and collaborators

Lead sponsor

Hiroshima University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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