- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07594470
Case-Based Learning for Bedside Lung Ultrasound Teaching in ICU
CBL Mode in Clinical Teaching of Bedside Lung Ultrasound in Intensive Care Unit: A Randomized Controlled Study
Study Overview
Status
Intervention / Treatment
Detailed Description
This single-center randomized controlled educational trial will be conducted in the Intensive Care Unit (ICU) of the First Affiliated Hospital of Wannan Medical College, China. The study aims to compare the effectiveness of Case-Based Learning (CBL) and traditional lecture-based teaching in bedside lung ultrasound (BLUE) education for residents and medical students participating in critical care rotations.
Participants will be randomized in a 1:1 ratio by computer-generated sequence into either the CBL group or the traditional teaching group. Both groups will receive a total of 8 hours of instruction delivered in two 4-hour sessions during their ICU rotation period.
In the CBL group, teaching will be guided by authentic clinical cases that include varied respiratory pathologies (e.g., pneumonia, pneumothorax, pulmonary edema). Each case will involve small-group discussion of diagnostic reasoning, interpretation of ultrasound findings, and supervised scanning practice at the bedside. Instructors will facilitate feedback and reflective learning, integrating theoretical concepts with clinical application.
In the traditional teaching group, participants will attend classroom lectures on ultrasound principles and watch instructor-led demonstrations of standardized BLUE examination techniques. Short hands-on practice sessions will follow under supervision but without case-based discussion or peer-feedback components.
All teaching sessions will be delivered by faculty certified in critical ultrasonography, using standardized instruction materials and the same ultrasound equipment and scanning protocols across groups. Data collection will occur within one week after completion of the teaching intervention. Primary outcomes include Objective Structured Clinical Examination (OSCE) score reflecting image acquisition, interpretation, and clinical reasoning. Secondary outcomes comprise written knowledge test scores and learner-reported measures of learning motivation and satisfaction.
All analyses will follow the intention-to-treat principle. Group differences will be tested using appropriate statistical methods (e.g., independent t-test or Mann-Whitney U test for continuous variables and chi-square test for categorical variables). The results will provide empirical evidence to guide optimization of bedside lung ultrasound education and the implementation of interactive, case-based teaching strategies in the context of intensive and emergency care training programs.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: qiancheng xu
- Phone Number: +86-18297529106
- Email: qianchengxu@wnmc.edu.cn
Study Locations
-
-
Anhui
-
Wuhu, Anhui, China, 241001
- The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
-
Contact:
- qiancheng xu
- Email: xu19871011@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Standardized residency trainees currently rotating in the Intensive Care Unit (ICU), specializing in Internal Medicine, Surgery, Emergency Medicine, Anesthesiology, or General Practice.
- Have completed institutional basic ultrasound theory training or possess preliminary ultrasound knowledge.
- Voluntarily participate and provide written informed consent.
- Able to complete the entire teaching and evaluation schedule (including written test and OSCE).
Exclusion Criteria:
- Prior formal training or certification in lung/critical care ultrasound.
- Unable to complete the study period due to rotation scheduling or absence.
- Decline or withdraw informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Case-Based Learning (CBL) Group
Participants study authentic emergency cases, analyze lung ultrasound images, perform bedside scanning under instructor facilitation, and discuss diagnostic reasoning in small groups.
|
Participants study authentic emergency cases, analyze lung ultrasound images, perform bedside scanning under instructor facilitation, and discuss diagnostic reasoning in small groups.
|
|
Active Comparator: Traditional Teaching Group
Participants receive conventional didactic lectures and instructor demonstration of BLUE examination followed by limited practice.
|
Participants receive conventional didactic lectures and instructor demonstration of BLUE examination followed by limited practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Structured Clinical Examination (OSCE) Total Score
Time Frame: Within one week after completion of the teaching sessions
|
he Objective Structured Clinical Examination (OSCE) total score (0-100 points) evaluates overall bedside lung ultrasound proficiency. It includes five weighted stations: (1) image acquisition and scanning technique (20 points), (2) image interpretation (20 points), (3) clinical decision-making (20 points), (4) structured case reporting and teamwork (20 points), and (5) emergency communication with patients or families (20 points). Each station is rated by three blinded assessors using standardized checklists and global rating scales. Higher scores indicate better ultrasound performance and clinical reasoning ability. Scale Range: 0 (poor performance) to 100 (excellent performance); higher = better |
Within one week after completion of the teaching sessions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Written Theoretical Knowledge Test Score
Time Frame: Within one week after the intervention
|
Description: Written examination assessing understanding of lung ultrasound principles, BLUE protocol workflow, and case analysis. The test includes multiple-choice, multiple-response, short-answer, and case-analysis items. Total score ranges from 0 to 100 points. Higher scores indicate greater theoretical knowledge mastery. Scale Range: 0 (lowest) to 100 (highest); higher = better |
Within one week after the intervention
|
|
Clinical Decision Substation Score
Time Frame: Within one week after intervention
|
Description: Subscore from the Objective Structured Clinical Examination (OSCE) Station 3, evaluating diagnostic reasoning and initial management decisions based on bedside lung ultrasound findings. Scored on a 0-20 point checklist by blinded assessors. Higher values reflect stronger clinical decision-making ability. Scale Range: 0 (lowest) to 20 (highest); higher = better |
Within one week after intervention
|
|
Self-Assessment Questionnaire Scores
Time Frame: Within one week after the intervention
|
Description: Study-specific questionnaire evaluating self-perceived improvement in learning motivation, clinical reasoning, teamwork, and communication. Each dimension consists of 5 dichotomous items (Yes = 1; No = 0). Scores are summarized as the proportion (%) of participants responding "Yes" in each domain. The possible range is 0%-100%; higher proportions indicate more participants reporting improvement. Scale Range: 0%-100%; higher = better perceived improvement |
Within one week after the intervention
|
|
Overall Learning Satisfaction Rating
Time Frame: Within one week after the intervention
|
Description: Overall satisfaction measured by a single 5-point Likert-type item (1 = Very dissatisfied, 2 = Dissatisfied, 3 = Neutral, 4 = Satisfied, 5 = Very satisfied). Reported as the proportion (%) of participants rating ≥4. Higher proportions reflect greater satisfaction with the assigned teaching method. Scale Range: 1-5 for individual ratings; 0%-100% for proportion ≥4; higher = better satisfaction |
Within one week after the intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2026-0511
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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