Cardiac ArrestRefCPRNCT03584867
CPR Refresher Role in Retaining Psychomotor Skills
A study testing refresher training at six months in people with Cardiac Arrest, run by Sultan Qaboos University at 2 sites in Oman.
Trial summary
The study aims to measure the effectiveness of refresher training after six months of baseline training on retention of CPR skills. Literature review and guidelines showed that there is significant decay in CPR skills after basic life support certification. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- refresher training at six months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesOman
- Study dates
- 1 Nov 2018to Aug 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All sultan Taboos university hospital staff in emergency department( nurses, doctors and respiratory therapists) who received basic life support training
- Age more than 18 years old
Who cannot join
- Medical illnesses that interfere with chest compression (back pain, wrist pain, knee pain)
- Pregnancy
- Providers who are scheduled for refresher training
Trial locations and contacts
2 sites in 1 country.
Oman2 sites, 2 recruiting
- Not yet recruiting
Sultan Qaboos University
Muscat, 115
Mahmood Aljufaili, M.D., 97191919, mahmood.j@squ.edu.om
Hajar AlJadidi, M.D., 92674471, hajar.j@resident.omsb.org
- Recruiting
Sultan Qaboos university hospital
Muscat
Hajar jadidi, MD, hajarkh2015@gmail.com
About this study
Official title: Scheduled CPR Refresher Training Role in Retaining Psychomotor Skills
The study aims to measure the effectiveness of refresher training after six months of baseline training on retention of CPR skills. Literature review and guidelines showed that there is significant decay in CPR skills after basic life support certification. This retention might be preserved as short as three months after basic life support certification. Frequent retraining within the standard two years of recertification was recommended. Recommendation did not specify the ideal timing and method for CPR refresher training. In this study, we are looking for a feasible, practical, easily applicable method for health care institute in order to maintain the required CPR skills. This study will be a randomized control trial in which the study group will be tested for their CPR skills at six and twelve months after CPR training before the start of the study and after six months assessment. The control group will be tested after twelve months from the initial training at the start of the research and with no CPR refresher in between. The outcome of the study will assess the effectiveness of a BLS refresher training at six months on retention of quality of CPR skills.
Read the detailed description
This is a prospective study that will enrol nurses, doctors and respiratory therapists of the Sultan Taboos university hospital,emergency departments from February 2018 until February 2019. All participants will be verbally consented before enrolment. Participants can withdraw from the study at any stage. All subjects will be assessed initially for their baseline skills of CPR. Assessment will be through measuring the baseline performance of the subjects. This will be two minutes of CPR in which chest compression rate, depth, chest recoil, interruption and ventilation will be assessed. CPR meter device will be used in each CPR assessment throughout the study. After that, all participants will receive CPR training which includes 15minutes standard CPR video followed by five minutes instructor- led teaching in manikins. Individual CPR performance will be assessed for each subject and data will be collected using a standardized data collection sheet. Next, groups will be randomized into two different groups using stratified sampling method to account for the years of experience. Participants will be divided into groups based on experience; 0-5, 5-10, 10-15, 15-20 and more than 20 years. Research randomizer (https://www.randomizer.org) program will be used for this purpose. Then, subjects will be randomized into study(group1) and control(group2) group. Both groups will be called after 6 months. Pre-assessment test will be conducted, which is similar to the baseline assessment test, for both groups using the same standardized data collection sheet. Then, study group will receive refresher training of CPR while the control group will be released with no training. Six months later, both groups will be called and CPR skills will be assessed again.
CPR performance will be monitor and assessed by using Little Anne manikin which has quality CPR (QCPR) monitoring through smart devises. This will provide data for each performer including chest compression rate and depth, chest recoil and adequate ventilation. Data of each subject will be stored in the devise and then will be transferred to software for storage and analysis.
- Conditions
- Cardiac Arrest
- Being tested
- refresher training at six months
- Keywords
- Basic life support, CPR skills, Training, High quality CPR
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
refresher training at six monthsOther
a 5 cycles of 30:2 compression to ventilation ratio will be offered to experimental group at six months from BLS certification.
| Study group | Role | What they receive |
|---|---|---|
| study Group | Experimental | refresher CPR Receives: Other: refresher training at six months |
| control | No intervention | NO refresher |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest compression
Chest compression rate ( number of compression per minute) Descriptive statistics will be presented as a mean ± standard deviation by using student t-test
Measured: 12 months
Secondary outcomes (3)
Ventilation rate
adequate or not adequate
Measured: 12 months
time of interruption
measured in seconds
Measured: 12 months
depth of compression
measured in millimetres
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 Nov 2018
- Primary completionJul 2019 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study. Experimental group would receive a refresher training at six months wherease the control receive not training.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmood AlJufaili, M.D., Principal investigator, Sultan Qaboos University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584867
- Sponsor's protocol ID
- SQU-EC/023/18
- Acronym
- RefCPR
- Status last verified
- Jul 2019
- First submitted
- 7 Mar 2018
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality issue
Publications
Jensen ML, Lippert F, Hesselfeldt R, Rasmussen MB, Mogensen SS, Jensen MK, Frost T, Ringsted C. The significance of clinical experience on learning outcome from resuscitation training-a randomised controlled study. Resuscitation. 2009 Feb;80(2):238-43. doi: 10.1016/j.resuscitation.2008.10.026. Epub 2008 Dec 5.
PubMed 19058890Niles D, Sutton RM, Donoghue A, Kalsi MS, Roberts K, Boyle L, Nishisaki A, Arbogast KB, Helfaer M, Nadkarni V. "Rolling Refreshers": a novel approach to maintain CPR psychomotor skill competence. Resuscitation. 2009 Aug;80(8):909-12. doi: 10.1016/j.resuscitation.2009.04.021. Epub 2009 May 20.
PubMed 19467759Yang CW, Yen ZS, McGowan JE, Chen HC, Chiang WC, Mancini ME, Soar J, Lai MS, Ma MH. A systematic review of retention of adult advanced life support knowledge and skills in healthcare providers. Resuscitation. 2012 Sep;83(9):1055-60. doi: 10.1016/j.resuscitation.2012.02.027. Epub 2012 Mar 3.
PubMed 22391016Nishiyama C, Iwami T, Murakami Y, Kitamura T, Okamoto Y, Marukawa S, Sakamoto T, Kawamura T. Effectiveness of simplified 15-min refresher BLS training program: a randomized controlled trial. Resuscitation. 2015 May;90:56-60. doi: 10.1016/j.resuscitation.2015.02.015. Epub 2015 Feb 24.
PubMed 25724354Oermann MH, Kardong-Edgren SE, Odom-Maryon T. Effects of monthly practice on nursing students' CPR psychomotor skill performance. Resuscitation. 2011 Apr;82(4):447-53. doi: 10.1016/j.resuscitation.2010.11.022. Epub 2011 Jan 11.
PubMed 21227563Kardong-Edgren SE, Oermann MH, Odom-Maryon T, Ha Y. Comparison of two instructional modalities for nursing student CPR skill acquisition. Resuscitation. 2010 Aug;81(8):1019-24. doi: 10.1016/j.resuscitation.2010.04.022. Epub 2010 Jun 2.
PubMed 20566391Niles DE, Nishisaki A, Sutton RM, Elci OU, Meaney PA, O'Connor KA, Leffelman J, Kramer-Johansen J, Berg RA, Nadkarni V. Improved Retention of Chest Compression Psychomotor Skills With Brief "Rolling Refresher" Training. Simul Healthc. 2017 Aug;12(4):213-219. doi: 10.1097/SIH.0000000000000228.
PubMed 28368963Soar J, Monsieurs KG, Ballance JH, Barelli A, Biarent D, Greif R, Handley AJ, Lockey AS, Richmond S, Ringsted C, Wyllie JP, Nolan JP, Perkins GD. European Resuscitation Council Guidelines for Resuscitation 2010 Section 9. Principles of education in resuscitation. Resuscitation. 2010 Oct;81(10):1434-44. doi: 10.1016/j.resuscitation.2010.08.014. No abstract available.
PubMed 20956044Sutton RM, Nadkarni V, Abella BS. "Putting it all together" to improve resuscitation quality. Emerg Med Clin North Am. 2012 Feb;30(1):105-22. doi: 10.1016/j.emc.2011.09.001. Epub 2011 Oct 15.
PubMed 22107978Meaney PA, Bobrow BJ, Mancini ME, Christenson J, de Caen AR, Bhanji F, Abella BS, Kleinman ME, Edelson DP, Berg RA, Aufderheide TP, Menon V, Leary M; CPR Quality Summit Investigators, the American Heart Association Emergency Cardiovascular Care Committee, and the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation. Cardiopulmonary resuscitation quality: [corrected] improving cardiac resuscitation outcomes both inside and outside the hospital: a consensus statement from the American Heart Association. Circulation. 2013 Jul 23;128(4):417-35. doi: 10.1161/CIR.0b013e31829d8654. Epub 2013 Jun 25.
PubMed 23801105Bhanji F, Donoghue AJ, Wolff MS, Flores GE, Halamek LP, Berman JM, Sinz EH, Cheng A. Part 14: Education: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S561-73. doi: 10.1161/CIR.0000000000000268. No abstract available.
PubMed 26473002
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scheduled CPR Refresher Training Role in Retaining Psychomotor Skills
- ClinicalTrials.gov ID
- NCT03584867
- Acronym / sponsor ID
- RefCPR / SQU-EC/023/18
- Conditions
- Cardiac Arrest
- Keywords
- Basic life support, CPR skills, Training, High quality CPR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 12 Jul 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.
The study aims to measure the effectiveness of refresher training after six months of baseline training on retention of CPR skills. Literature review and guidelines showed that there is significant decay in CPR skills after basic life support certification. This retention might be preserved as short as three months after basic life support certification. Frequent retraining within the standard two years of recertification was recommended. Recommendation did not specify the ideal timing and method for CPR refresher training. In this study, we are looking for a feasible, practical, easily applicable method for health care institute in order to maintain the required CPR skills. This study will be a randomized control trial in which the study group will be tested for their CPR skills at six and twelve months after CPR training before the start of the study and after six months assessment. The control group will be tested after twelve months from the initial training at the start of the research and with no CPR refresher in between. The outcome of the study will assess the effectiveness of a BLS refresher training at six months on retention of quality of CPR skills.
Detailed description
This is a prospective study that will enrol nurses, doctors and respiratory therapists of the Sultan Taboos university hospital,emergency departments from February 2018 until February 2019. All participants will be verbally consented before enrolment. Participants can withdraw from the study at any stage. All subjects will be assessed initially for their baseline skills of CPR. Assessment will be through measuring the baseline performance of the subjects. This will be two minutes of CPR in which chest compression rate, depth, chest recoil, interruption and ventilation will be assessed. CPR meter device will be used in each CPR assessment throughout the study. After that, all participants will receive CPR training which includes 15minutes standard CPR video followed by five minutes instructor- led teaching in manikins. Individual CPR performance will be assessed for each subject and data will be collected using a standardized data collection sheet. Next, groups will be randomized into two different groups using stratified sampling method to account for the years of experience. Participants will be divided into groups based on experience; 0-5, 5-10, 10-15, 15-20 and more than 20 years. Research randomizer (https://www.randomizer.org) program will be used for this purpose. Then, subjects will be randomized into study(group1) and control(group2) group. Both groups will be called after 6 months. Pre-assessment test will be conducted, which is similar to the baseline assessment test, for both groups using the same standardized data collection sheet. Then, study group will receive refresher training of CPR while the control group will be released with no training. Six months later, both groups will be called and CPR skills will be assessed again.
CPR performance will be monitor and assessed by using Little Anne manikin which has quality CPR (QCPR) monitoring through smart devises. This will provide data for each performer including chest compression rate and depth, chest recoil and adequate ventilation. Data of each subject will be stored in the devise and then will be transferred to software for storage and analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled study. Experimental group would receive a refresher training at six months wherease the control receive not training.
| Arm | Type | Receives |
|---|---|---|
| study Group | Experimental | Other: refresher training at six monthsrefresher CPR |
| control | No intervention | –NO refresher |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All sultan Taboos university hospital staff in emergency department( nurses, doctors and respiratory therapists) who received basic life support training
- Age more than 18 years old
Key exclusion criteria (3 listed)
- Medical illnesses that interfere with chest compression (back pain, wrist pain, knee pain)
- Pregnancy
- Providers who are scheduled for refresher training
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 |
|---|---|---|
| refresher training at six monthsa 5 cycles of 30:2 compression to ventilation ratio will be offered to experimental group at six months from BLS certification. | Other | study Group |
Primary outcome
Chest compression
Time frame: 12 months
Chest compression rate ( number of compression per minute) Descriptive statistics will be presented as a mean ± standard deviation by using student t-test
3 secondary outcomes
Ventilation rate
Time frame: 12 months
time of interruption
Time frame: 12 months
depth of compression
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Results publication: PubMed 19058890Jensen ML, Lippert F, Hesselfeldt R, Rasmussen MB, Mogensen SS, Jensen MK, Frost T, Ringsted C. The significance of clinical experience on learning outcome from resuscitation training-a randomised controlled study. Resuscitation. 2009 Feb;80(2):238-43. doi: 10.1016/j.resuscitation.2008.10.026. Epub 2008 Dec 5.
- Results publication: PubMed 19467759Niles D, Sutton RM, Donoghue A, Kalsi MS, Roberts K, Boyle L, Nishisaki A, Arbogast KB, Helfaer M, Nadkarni V. "Rolling Refreshers": a novel approach to maintain CPR psychomotor skill competence. Resuscitation. 2009 Aug;80(8):909-12. doi: 10.1016/j.resuscitation.2009.04.021. Epub 2009 May 20.
- Results publication: PubMed 22391016Yang CW, Yen ZS, McGowan JE, Chen HC, Chiang WC, Mancini ME, Soar J, Lai MS, Ma MH. A systematic review of retention of adult advanced life support knowledge and skills in healthcare providers. Resuscitation. 2012 Sep;83(9):1055-60. doi: 10.1016/j.resuscitation.2012.02.027. Epub 2012 Mar 3.
- Results publication: PubMed 25724354Nishiyama C, Iwami T, Murakami Y, Kitamura T, Okamoto Y, Marukawa S, Sakamoto T, Kawamura T. Effectiveness of simplified 15-min refresher BLS training program: a randomized controlled trial. Resuscitation. 2015 May;90:56-60. doi: 10.1016/j.resuscitation.2015.02.015. Epub 2015 Feb 24.
- Results publication: PubMed 21227563Oermann MH, Kardong-Edgren SE, Odom-Maryon T. Effects of monthly practice on nursing students' CPR psychomotor skill performance. Resuscitation. 2011 Apr;82(4):447-53. doi: 10.1016/j.resuscitation.2010.11.022. Epub 2011 Jan 11.
- Results publication: PubMed 20566391Kardong-Edgren SE, Oermann MH, Odom-Maryon T, Ha Y. Comparison of two instructional modalities for nursing student CPR skill acquisition. Resuscitation. 2010 Aug;81(8):1019-24. doi: 10.1016/j.resuscitation.2010.04.022. Epub 2010 Jun 2.
- Results publication: PubMed 28368963Niles DE, Nishisaki A, Sutton RM, Elci OU, Meaney PA, O'Connor KA, Leffelman J, Kramer-Johansen J, Berg RA, Nadkarni V. Improved Retention of Chest Compression Psychomotor Skills With Brief "Rolling Refresher" Training. Simul Healthc. 2017 Aug;12(4):213-219. doi: 10.1097/SIH.0000000000000228.
- Results publication: PubMed 20956044Soar J, Monsieurs KG, Ballance JH, Barelli A, Biarent D, Greif R, Handley AJ, Lockey AS, Richmond S, Ringsted C, Wyllie JP, Nolan JP, Perkins GD. European Resuscitation Council Guidelines for Resuscitation 2010 Section 9. Principles of education in resuscitation. Resuscitation. 2010 Oct;81(10):1434-44. doi: 10.1016/j.resuscitation.2010.08.014. No abstract available.
- Results publication: PubMed 22107978Sutton RM, Nadkarni V, Abella BS. "Putting it all together" to improve resuscitation quality. Emerg Med Clin North Am. 2012 Feb;30(1):105-22. doi: 10.1016/j.emc.2011.09.001. Epub 2011 Oct 15.
- Results publication: PubMed 23801105Meaney PA, Bobrow BJ, Mancini ME, Christenson J, de Caen AR, Bhanji F, Abella BS, Kleinman ME, Edelson DP, Berg RA, Aufderheide TP, Menon V, Leary M; CPR Quality Summit Investigators, the American Heart Association Emergency Cardiovascular Care Committee, and the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation. Cardiopulmonary resuscitation quality: [corrected] improving cardiac resuscitation outcomes both inside and outside the hospital: a consensus statement from the American Heart Association. Circulation. 2013 Jul 23;128(4):417-35. doi: 10.1161/CIR.0b013e31829d8654. Epub 2013 Jun 25.
- Results publication: PubMed 26473002Bhanji F, Donoghue AJ, Wolff MS, Flores GE, Halamek LP, Berman JM, Sinz EH, Cheng A. Part 14: Education: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S561-73. doi: 10.1161/CIR.0000000000000268. No abstract available.
- Individual participant dataSharing planned: No. Confidentiality issue
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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.
Mahmood AlJufaili, M.D. principal investigator
Sultan Qaboos University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing refresher training at six months in people with Cardiac Arrest, run by Sultan Qaboos University at 2 sites in Oman.
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 3 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: status not confirmed, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmood ALjufaili, M.D. (97191919, mahmood.j@squ.edu.om), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest compression (time frame: 12 months). 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 NCT03584867, which also lists 11 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 16 Jul 2019.