Different Re-training Durations in BLS Training Among Non-Professionals

March 4, 2025 updated by: National Taiwan University Hospital

Different Re-training Durations in Basic Life Support Training Among Non-Professionals: A Three-Arm Randomized Controlled Trial

Previous studies on compression-only CPR and AED training for the general public have primarily focused on the optimal retraining interval. However, the impact of different retraining durations remains unclear. This study explores how varying practice durations in Basic Life Support (BLS) training affect BLS performance among non-professionals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. 45-minute retraining sessions
  2. 60-minute retraining sessions
  3. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 45-minute retraining
45-minute retraining sessions
Other: Retraining
Each retraining session begins with a 15-minute comprehensive review, followed by hands-on practice
Experimental: 60-minute retraining
60-minute retraining sessions
Other: Retraining
Each retraining session begins with a 15-minute comprehensive review, followed by hands-on practice
Experimental: 75-minute retraining
75-minute retraining sessions
Other: Retraining
Each retraining session begins with a 15-minute comprehensive review, followed by hands-on practice

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ming-Ju Hsieh, MD, PhD, National Taiwan University Hospital, Taipei, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202007002RINB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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