- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06867653
Different Re-training Durations in BLS Training Among Non-Professionals
Different Re-training Durations in Basic Life Support Training Among Non-Professionals: A Three-Arm Randomized Controlled Trial
Study Overview
Detailed Description
In this study, participants first underwent compression-only CPR and AED training. Before training, they completed a questionnaire on their perspectives on BLS retraining and basic demographic information. Knowledge tests, skill assessments, and attitude and confidence questionnaires were conducted both before and after training. During the skill assessment, two cameras recorded the process from different angles: one positioned from the feet towards the head of the manikin and the other from the left chest towards the right chest. Instructors, blinded to group allocation, later reviewed the recordings and assessed participants' performance using an evaluation form. Additionally, chest compressions were recorded using a computerized manikin (SkillReporter Resusci Anne®, Laerdal, Stavanger, Norway).
Participants were then randomly assigned to one of three groups based on different retraining durations:
- 45-minute retraining sessions
- 60-minute retraining sessions
- 75-minute retraining sessions
All three groups underwent skill assessments and knowledge tests every three months before their respective retraining sessions. The retraining skill assessments followed the same procedure as the initial training. Each retraining session began with a 15-minute comprehensive review, followed by hands-on practice. Each participant practiced for approximately five minutes per cycle, which included two minutes of chest compressions, one minute of AED application, one minute of feedback, and one minute for role-switching. Based on this structure, participants in the 45-minute group completed two practice cycles, those in the 60-minute group completed three cycles, and those in the 75-minute group completed four cycles.
Both the initial training and retraining followed the American Heart Association (AHA) Heartsaver® CPR+AED course guidelines, with a participant-to-manikin ratio of 3:1 and a maximum of six participants per instructor. One year after the initial training, before the final skill assessment, participants completed the knowledge test and the attitude and confidence questionnaire. After the final skill assessment, they completed the CPR retraining perspectives questionnaire.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shu-Ting Chen
- Phone Number: 265632 886223123456
- Email: erdrmjhsieh@gmail.com
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Ming-Ju Hsieh, MD, PhD
- Phone Number: 265632 886223123456
- Email: erdrmjhsieh@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age >=18 years old
Exclusion Criteria:
- Subjects whose physical condition is unsuitable for the CPR training, such as those unable to squat, extend their arms fully, or individuals who are blind or deaf.
- Healthcare professionals and students majoring in healthcare-related fields.
- Individuals unwilling to sign the informed consent form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 45-minute retraining
45-minute retraining sessions
|
Each retraining session begins with a 15-minute comprehensive review, followed by hands-on practice
|
|
Experimental: 60-minute retraining
60-minute retraining sessions
|
Each retraining session begins with a 15-minute comprehensive review, followed by hands-on practice
|
|
Experimental: 75-minute retraining
75-minute retraining sessions
|
Each retraining session begins with a 15-minute comprehensive review, followed by hands-on practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average compression rate
Time Frame: one year after the initial training
|
The average compression rate during the skill assessment and the proportion of participants in each group with an average compression rate between 100-120 compressions per minute one year after the initial training
|
one year after the initial training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average compression depth
Time Frame: 3, 6, 9 and 12 months after the initial training
|
The average compression depth and the proportion of participants in each group with an average compression depth between 5-6 cm during the skill assessment every three months
|
3, 6, 9 and 12 months after the initial training
|
|
Average compression rate
Time Frame: 3 month, 6 months and 9 months after initial training
|
The average compression rate and the proportion of participants in each group with an average compression rate between 100-120 compressions per minute at 3 month, 6 months and 9 months after initial training.
|
3 month, 6 months and 9 months after initial training
|
|
Chest recoil
Time Frame: 3, 6, 9 and 12 months after the initial training
|
The proportion of complete chest recoil in each group every three months
|
3, 6, 9 and 12 months after the initial training
|
|
Flow time
Time Frame: 3, 6, 9 and 12 months after the initial training
|
The percentage of compression time over total assessment time in each group during the skill assessment
|
3, 6, 9 and 12 months after the initial training
|
|
Correct hand placement
Time Frame: 3, 6, 9 and 12 months after the initial training
|
The proportion of correct hand placement in each group during the skill assessment every three months
|
3, 6, 9 and 12 months after the initial training
|
|
Pass rate
Time Frame: 3, 6, 9 and 12 months after the initial training
|
The proportion of participants passing the assessment evaluated by instructors
|
3, 6, 9 and 12 months after the initial training
|
|
Passing rates for each item
Time Frame: 3, 6, 9 and 12 months after the initial training
|
The passing rate for each item on the evaluation form
|
3, 6, 9 and 12 months after the initial training
|
|
Attitude
Time Frame: one year after the initial training
|
The attitude questionnaire consists of two questions, each rated using a Likert scale, including 'strongly disagree,' 'disagree,' 'neutral,' 'agree,' and 'strongly agree.'
When calculating the scores, 'strongly disagree' is assigned 1 point, 'disagree' 2 points, 'neutral' 3 points, 'agree' 4 points, and 'strongly agree' 5 points.
A higher score indicates that participants place greater importance on the item.
|
one year after the initial training
|
|
Confidence
Time Frame: one year after the initial training
|
The confidence questionnaire consists of three questions, each rated using a Likert scale, including 'strongly disagree,' 'disagree,' 'neutral,' 'agree,' and 'strongly agree.'
When calculating the scores, 'strongly disagree' is assigned 1 point, 'disagree' 2 points, 'neutral' 3 points, 'agree' 4 points, and 'strongly agree' 5 points.
A higher score indicates greater confidence.
|
one year after the initial training
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perspectives questionnaire on retraining
Time Frame: one year after the initial training
|
The perspective questionnaire on retraining consists of two questions: (1) How long do you think the interval for CPR retraining should be?
(2) How long do you think the duration of a CPR retraining course should be?
These two questions are open-ended.
|
one year after the initial training
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ming-Ju Hsieh, MD, PhD, National Taiwan University Hospital, Taipei, Taiwan
Study record dates
Study Major Dates
Study Start (Actual)
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
- 202007002RINB
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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