Basic Life Support Training CourseNCT03511872
Peers Vs Professionals in Basic Life Support Training
A study testing Basic life support training in people with Basic Life Support Training Course, run by Damascus University.
Trial summary
An Evaluation of Peer-led basic life support training course compared with professional-led course in a limited resource environment; A randomized controlled trial Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Basic Life Support Training Course
- What is being tested?
- Basic life support training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 1 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medical student from 1st, 2nd and third year at Syrian Private University.
- Sign the consent form.
Who cannot join
- presence of any health problems preventing students from doing physical exercise.
- any serious acute or chronic illness (infectious, psychological, physical).
- scheduling conflict between the date of the BLS course and other faculty's classes or exams.
- missing the course or the assessment for any reason.
- refusing to sign the consent and having any prior experience in BLS skills (previously trained on BLS).
About this study
Official title: Peers Versus Professional Training of Basic Life Support in Syria: a Randomized Controlled Trial
An Evaluation of Peer-led basic life support training course compared with professional-led course in a limited resource environment; A randomized controlled trial
Read the detailed description
Peer training has been identified as a useful tool for delivering undergraduate training in basic life support (BLS) which is fundamental as an initial response in cases of emergency.
This study aimed to (1) Evaluate the efficacy of peer-led model in basic life support training among medical students in their first three years of study, compared to professional-led training and (2) To assess the efficacy of the course program and students' satisfaction of peer-led training.
A randomized controlled trial with blinded assessors will be conducted on 72 medical students from the pre-clinical years (1st to 3rd years in Syria) at Syrian Private University. Students will be randomly assigned to peer-led or to professional-led training group for one-day-course of basic life support skills.
Analysis will be done on students who underwent checklist based assessment using objective structured clinical examination design (OSCE) (practical assessment of BLS skills) and answered BLS knowledge checkpoint-questionnaire.
- Conditions
- Basic Life Support Training Course
- Being tested
- Basic life support training
- Keywords
- Basic life support, cardiopulmonary resuscitation, medical undergraduate students, crisis, randomized controlled trial.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic life support trainingOther
A course design was made to be consistent with ERC guidelines with local modifications made by emergency professionals in duration, instructor-to-trainee ratio, course materials, methods to deliver these materials theoretically, and the type of the manikin used to practice CPR. One-day-course consisting of 75, 20, 20, 20 minutes for theoretical BLS, chocking, recovery position, the practical representation of BLS scenario respectively followed by 40-minute practical training on BLS skills for each subgroup. Both arms of the study follow the same timeline and no extra time is given to any group.
Same manikins were used for the training and the assessment. On the day of the experiment students in each arm are divided into 4 subgroups of maximum 9 students, each led by two trainers of BLS skills with a maximum ratio of 2 instructors to 9 students per group.
| Study group | Role | What they receive |
|---|---|---|
| Peers' group | Experimental | 36 Medical students are allocated randomly to Peers' group where they are trained on BLS skills by senior students.
Four students from the latest three years of study in medical schools in Syria (4th, 5th, and 6th) are randomly selected and enrolled to be instructors for basic life support training course to transfer the resuscitation skills to medical students from pre-clinical years. Receives: Other: Basic life support training |
| Professionals' group | Experimental | 36 students are allocated randomly to professionals' group where they are trained on BLS skills by professional trainers in emergency. Four professionals (2 emergency doctors, cardiologist and anesthesiologist) are leading training to the control group to deliver the basic life support training course with the same duration and content as the intervention group. Receives: Other: Basic life support training |
What is being measured
The primary outcome is the main question the study is designed to answer.
BLS practical skills
A practical simulated scenario assessment using a checklist based evaluation in objective structured clinical examination (OSCE) design. The checklist is constructed in accordance to European resuscitation council (ERC) guideline. Students should perform each point correctly to pass the assessment (1- Safe approach, 2- call for help, 3- opening airway, 4-checking cardiopulmonary situation, 5- call ambulance, 6- CPR with effective depth, 7-rate and 8-position, 9-rescue breaths).
Measured: Training and assessment were held at the same day of the experiment for both groups, 1) within 24 hours of providing the bls training course.
Secondary outcomes (2)
BLS knowledge questionnaire
a 20-item questionnaire with 3 checkpoints per item (60-point-scale) derived from ERC materials after testing the applicability of the questionnaire by a pilot study.
Measured: Training and assessment were held at the same day of the experiment for both groups. 1) within 24 hours of providing the bls training course.
Students' evaluation of BLS course survey
Students' reported outcomes using American Heart Association (AHA) survey of BLS course evaluation. This survey aims to investigate students' satisfaction and their opinions about the course.
Measured: Training and assessment were held at the same day of the experiment for both groups. 1) within 24 hours of providing the bls training course.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start1 Mar 2016
- Primary completion1 May 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Basic Life Support Training CourseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial with blinded assessors on medical students from the pre-clinical years (1st to 3rd years in Syria) at Syrian Private University. Students are randomly assigned to peer-led or to professional-led training group for one-day-course of basic life support skills.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511872
- Sponsor's protocol ID
- 2210110616
- Status last verified
- Apr 2018
- First submitted
- 12 Apr 2018
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Association AH. ECC Course Evaluation. 2012.
Perkins GD, Handley AJ, Koster RW, Castren M, Smyth MA, Olasveengen T, Monsieurs KG, Raffay V, Grasner JT, Wenzel V, Ristagno G, Soar J; Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation. Resuscitation. 2015 Oct;95:81-99. doi: 10.1016/j.resuscitation.2015.07.015. Epub 2015 Oct 15. No abstract available.
PubMed 26477420Charlier N, Van Der Stock L, Iserbyt P. Peer-assisted Learning in Cardiopulmonary Resuscitation: The Jigsaw Model. J Emerg Med. 2016 Jan;50(1):67-73. doi: 10.1016/j.jemermed.2015.04.002. Epub 2015 Jun 20.
PubMed 26099910Fujiwara T, Nishimura M, Honda R, Nishiyama T, Nomoto M, Kobayashi N, Ikeda M. Comparison of peer-led versus professional-led training in basic life support for medical students. Adv Med Educ Pract. 2011 Jul 26;2:187-91. doi: 10.2147/AMEP.S22948. Print 2011.
PubMed 23745089Perkins GD, Hulme J, Bion JF. Peer-led resuscitation training for healthcare students: a randomised controlled study. Intensive Care Med. 2002 Jun;28(6):698-700. doi: 10.1007/s00134-002-1291-9. Epub 2002 Apr 24.
PubMed 12107673
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peers Versus Professional Training of Basic Life Support in Syria: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03511872
- Acronym / sponsor ID
- 2210110616
- Conditions
- Basic Life Support Training Course
- Keywords
- Basic life support, cardiopulmonary resuscitation, medical undergraduate students, crisis, randomized controlled trial.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 30 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Evaluation of Peer-led basic life support training course compared with professional-led course in a limited resource environment; A randomized controlled trial
Detailed description
Peer training has been identified as a useful tool for delivering undergraduate training in basic life support (BLS) which is fundamental as an initial response in cases of emergency.
This study aimed to (1) Evaluate the efficacy of peer-led model in basic life support training among medical students in their first three years of study, compared to professional-led training and (2) To assess the efficacy of the course program and students' satisfaction of peer-led training.
A randomized controlled trial with blinded assessors will be conducted on 72 medical students from the pre-clinical years (1st to 3rd years in Syria) at Syrian Private University. Students will be randomly assigned to peer-led or to professional-led training group for one-day-course of basic life support skills.
Analysis will be done on students who underwent checklist based assessment using objective structured clinical examination design (OSCE) (practical assessment of BLS skills) and answered BLS knowledge checkpoint-questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial with blinded assessors on medical students from the pre-clinical years (1st to 3rd years in Syria) at Syrian Private University. Students are randomly assigned to peer-led or to professional-led training group for one-day-course of basic life support skills.
| Arm | Type | Receives |
|---|---|---|
| Peers' group | Experimental | Other: Basic life support training36 Medical students are allocated randomly to Peers' group where they are trained on BLS skills by senior students. Four students from the latest three years of study in medical schools in Syria (4th, 5th, and 6th) are randomly selected and enrolled to be instructors for basic life support training course to transfer the resuscitation skills to medical students from pre-clinical years. |
| Professionals' group | Experimental | Other: Basic life support training36 students are allocated randomly to professionals' group where they are trained on BLS skills by professional trainers in emergency. Four professionals (2 emergency doctors, cardiologist and anesthesiologist) are leading training to the control group to deliver the basic life support training course with the same duration and content as the intervention group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Medical student from 1st, 2nd and third year at Syrian Private University.
- Sign the consent form.
Key exclusion criteria (5 listed)
- presence of any health problems preventing students from doing physical exercise.
- any serious acute or chronic illness (infectious, psychological, physical).
- scheduling conflict between the date of the BLS course and other faculty's classes or exams.
- missing the course or the assessment for any reason.
- refusing to sign the consent and having any prior experience in BLS skills (previously trained on BLS).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic life support trainingA course design was made to be consistent with ERC guidelines with local modifications made by emergency professionals in duration, instructor-to-trainee ratio, course materials, methods to deliver these materials theoretically, and the type of the manikin used to practice CPR. One-day-course consisting of 75, 20, 20, 20 minutes for theoretical BLS, chocking, recovery position, the practical representation of BLS scenario respectively followed by 40-minute practical training on BLS skills for each subgroup. Both arms of the study follow the same timeline and no extra time is given to any group. Same manikins were used for the training and the assessment. On the day of the experiment students in each arm are divided into 4 subgroups of maximum 9 students, each led by two trainers of BLS skills with a maximum ratio of 2 instructors to 9 students per group. | Other | Peers' group, Professionals' group |
Primary outcome
BLS practical skills
Time frame: Training and assessment were held at the same day of the experiment for both groups, 1) within 24 hours of providing the bls training course.
A practical simulated scenario assessment using a checklist based evaluation in objective structured clinical examination (OSCE) design. The checklist is constructed in accordance to European resuscitation council (ERC) guideline. Students should perform each point correctly to pass the assessment (1- Safe approach, 2- call for help, 3- opening airway, 4-checking cardiopulmonary situation, 5- call ambulance, 6- CPR with effective depth, 7-rate and 8-position, 9-rescue breaths).
2 secondary outcomes
BLS knowledge questionnaire
Time frame: Training and assessment were held at the same day of the experiment for both groups. 1) within 24 hours of providing the bls training course.
Students' evaluation of BLS course survey
Time frame: Training and assessment were held at the same day of the experiment for both groups. 1) within 24 hours of providing the bls training course.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- BackgroundAssociation AH. ECC Course Evaluation. 2012.
- Background: PubMed 26477420Perkins GD, Handley AJ, Koster RW, Castren M, Smyth MA, Olasveengen T, Monsieurs KG, Raffay V, Grasner JT, Wenzel V, Ristagno G, Soar J; Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation. Resuscitation. 2015 Oct;95:81-99. doi: 10.1016/j.resuscitation.2015.07.015. Epub 2015 Oct 15. No abstract available.
- Background: PubMed 26099910Charlier N, Van Der Stock L, Iserbyt P. Peer-assisted Learning in Cardiopulmonary Resuscitation: The Jigsaw Model. J Emerg Med. 2016 Jan;50(1):67-73. doi: 10.1016/j.jemermed.2015.04.002. Epub 2015 Jun 20.
- Background: PubMed 23745089Fujiwara T, Nishimura M, Honda R, Nishiyama T, Nomoto M, Kobayashi N, Ikeda M. Comparison of peer-led versus professional-led training in basic life support for medical students. Adv Med Educ Pract. 2011 Jul 26;2:187-91. doi: 10.2147/AMEP.S22948. Print 2011.
- Background: PubMed 12107673Perkins GD, Hulme J, Bion JF. Peer-led resuscitation training for healthcare students: a randomised controlled study. Intensive Care Med. 2002 Jun;28(6):698-700. doi: 10.1007/s00134-002-1291-9. Epub 2002 Apr 24.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Basic life support training in people with Basic Life Support Training Course, run by Damascus University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BLS practical skills (time frame: Training and assessment were held at the same day of the experiment for both groups, 1) within 24 hours of providing the bls training course.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03511872, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.