Cardiopulmonary ResuscitationBLSPilotNCT01361919
Three Different Cardiopulmonary Resuscitation (CPR) Training Methods
A study testing Feedback During CPR Training and Testing, No Feedback Group and Feedback during CPR Training Not Testing in people with Cardiopulmonary Resuscitation, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The goal of this study is to compare three methods of teaching medical and nursing students basic life saving skills. The standard method will teach students how to push on the chest and to analyze the heart rhythm using a regular monitor. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Resuscitation
- What is being tested?
- Feedback During CPR Training and Testing, No Feedback Group and Feedback during CPR Training Not Testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 298 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- medical or nursing students aged >= 18
Who cannot join
- unwilling to sign consent, or
- unable to return in 3 months time for follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Benefits of a Simplified Method for CPR Training of Medical Professionals: A Randomized Controlled Study
The goal of this study is to compare three methods of teaching medical and nursing students basic life saving skills. The standard method will teach students how to push on the chest and to analyze the heart rhythm using a regular monitor. The newer approach will teach the same skills but use a special heart monitor that provides both visual and verbal reminders. The third approach will combine both the standard and newer approaches to teaching. Our study would like to find out the better way to teach these skills and to create a standard way to grade how well students perform. This study will measure how deep and how fast the students push on the manikin's chest in a certain amount of time. Other goals include measuring how well the students use the heart monitor to deliver shocks and analyze the heart rhythm, how many breaths per minute they give, how long their hands are off the manikin and how well they think they performed overall.
Read the detailed description
The survival rates for out-of-hospital cardiac arrest (OCA) remain low (approximately 5%), despite recent advances in advanced cardiac life support (ACLS) and expansion of emergency medical services (EMS) across Ontario and Canada. Although the survival rates for in-hospital cardiac arrest are higher, less than 20% ultimately survive to discharge. One of the most important determinants of survival from cardiac arrest appears to be initiation of early and effective chest compressions. Yet the quality of cardiopulmonary resuscitation (CPR) and basic life support (BLS) delivered by first responders is often poor. CPR appears to be delivered inconsistently, incompletely and with undue delays in both the in-hospital and out-of-hospital setting. In an effort to improve cardiac arrest outcomes, focus has recently shifted to methods for training in CPR. Optimal BLS (involving chest compressions, artificial ventilation, and the use of an automated external defibrillator where available) is difficult to perform well, to teach, and to retain at a high skill level. Most BLS training programs use hands-on instruction, printed materials, and global assessment for evaluation, which to date have not been shown to impact on the quality of the CPR/BLS provided. Guidelines for BLS have changed substantially since 2005, and the efficacy of the teaching programs aimed at laypersons or primary providers of emergency care is unknown. A potential result of these limitations in the teaching, training, evaluation, and retention of BLS skills is that CPR continues to be poorly performed both by trained lay rescuers and professional caregivers.
New technologies incorporated into commercially available defibrillators may help in the training and evaluation of BLS skills. These devices allow measurement of chest compression depth and rate and ventilation frequency with continuous real-time feedback provided to the caregiver by means of an on-screen icon, which is a simple visual measure of integrated CPR efficacy, as well as verbal prompts to encourage best performance. Electronic information is stored in the defibrillator for subsequent off-line analysis which can be used to provide additional visual feedback. Perhaps most importantly, these tools provide a quantitative measure of the quality of the resuscitation effort by integrating the various aspects of CPR performance.
To date no clinical study has assessed if such tools would facilitate both the training and testing of CPR skills using the new 2005 cardiac arrest guidelines. To answer this question, the investigators propose to conduct a clinical trial involving medical and nursing students (considered "lay rescuers"), randomized to three different teaching strategies. The advantage of this population is that they are relatively easy to access and in addition, provide a homogeneous population with similarities in background, education, motivation and personal expectations. They also represent a large proportion of individuals who, in time, will be exposed to and will respond to in-hospital cardiac arrests. By using medical and nursing students who are still in the formative stages of their concepts of allied health members, the investigators hope to provide an opportunity for them to work with, about and from each other.
The control group will receive standard teaching of BLS according to the ILCOR 2005 Guidelines, including appropriate chest compression rate, depth, and chest recoil with minimization of "hands-off" time, appropriate ventilation, and use of a standard defibrillator (Zoll M series). The first intervention group will receive training supplemented by the use of a novel defibrillator (Zoll R Series) which allows for real-time continuous feedback with both visual and audio prompts to optimize CPR performance, as well as additional off-line review of details of chest compressions (including rate and depth), "hands-off" time (time spent not doing chest compressions), and therapy sequencing. The second intervention group will receive training with the novel defibrillator (Zoll R Series) but will be tested with the standard defibrillator (Zoll M series).
Two hundred and forty consenting students will be randomly assigned to the standard training ("control") group, or to training and testing using the advanced feedback features ("intervention group 1"), or to training using the advanced feedback features but tested using the standard defibrillator ("intervention group 2"), in groups of 2. After a two hour training period all participants will be tested for approximately 5 minutes. Students in the control and intervention groups will be randomized to three groups: R-Series, R series and M series or M-Series defibrillators and tested using a scenario similar to the training session.
The primary outcome is total CPR fraction (percentage of time doing chest compressions during the scenario). Secondary outcomes are CPR fraction per minute, average rate of compressions per minute, total recorded hands-off time, average depth of compressions, and the average integrated "icon fullness" as an approximation of cardiac output. Overall performance in terms of integrated psychomotor skills, reasons for hands-off time, appropriate versus inappropriate use of the AED in terms of rhythm analysis, shock delivery and study participant self-assessment of performance will also be measured. After a 3 month period, students will be re-tested using the same testing scenario to assess for skill retention. No further BLS training will be given prior to retesting.
This will be the first study to evaluate objectively and in a controlled manner the usefulness of these new technologies in the teaching, learning and evaluation of CPR/BLS.
- Conditions
- Cardiopulmonary Resuscitation
- Being tested
- Feedback During CPR Training and Testing, No Feedback Group, Feedback during CPR Training Not Testing
- Keywords
- compressions, quality, teaching method, feedback, CPR performance, Cardiopulmonary resuscitation (CPR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback During CPR Training and TestingProcedure or surgery
Students in this group will receive training in BLS skills according to the 2005 AHA/ILCOR guidelines, using the ZOLL R Series™ defibrillator with an attached accelerometer pad that will be placed on the sternum of the manikin and visible to the user. Participants will be taught to use and follow the audio and visual feedback provided by the accelerometer and defibrillator to optimize their CPR performance (depth, rate, and minimal "hands-off" time). After the simulated cardiac arrest scenario, a data card containing the raw data collected from the accelerometer and defibrillator will be downloaded onto a laptop and used as a demonstration and training tool.
No Feedback GroupProcedure or surgery
Also called simulation CPR training
A standard no "feedback" defibrillator (ZOLL M series) will be used for teaching, immediate testing and 12 week (retention) testing. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. During the test, subjects will be informed that data on their performance will be recorded but they will not be told how this will occur.
Feedback during CPR Training Not TestingProcedure or surgery
Also called Feedback during simulation testing
Students in this group will be tested using a five minute basic vfib arrest scenario and an R-series defibrillator and told to perform compressions on top of the accelerometer pad. The hexagonal icon will be visible but no prompting on its usage will be delivered during testing.
| Study group | Role | What they receive |
|---|---|---|
| Feedback During CPR Training and Testing | Experimental | A "feedback" defibrillator (ZOLL R series) will be used at teaching, immediate testing and 12 week (retention) testing. A simulation manikin with an attached accelerometer pad on its sternum will be used to collect CPR performance data. Subjects will be told to perform compressions on top of the accelerometer pad and will be taught to use and follow the audio and visual feedback to optimize their CPR performance. After training, the raw data collected by the accelerometer will be used as a demonstration and training tool, to correct the subjects' performance by visually demonstrating the difference between ideal and suboptimal CPR performance. Testing will be carried out with the use of a "feedback" defibrillator. Receives: Procedure: Feedback During CPR Training and Testing; Procedure: Feedback during CPR Training Not Testing |
| Feedback during CPR Training Not Testing | Active comparator | A "feedback" defibrillator will be used for teaching, with a standard no "feedback" defibrillator used at immediate and 12 week (retention) testing to assess if the techniques the students' learned during training are transferable to devices without "feedback". In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. Receives: Procedure: Feedback During CPR Training and Testing |
| No Feedback Group | Placebo comparator | A standard no "feedback" defibrillator (ZOLL M series) will be used for teaching, immediate testing and 12 week (retention) testing. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. During the test, subjects will be informed that data on their performance will be recorded but they will not be told how this will occur. Receives: Procedure: No Feedback Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPR Depth
Depth of chest compressions measured in millimeters
Measured: baseline
CPR Rate
rate of chest compression per minute
Measured: baseline
Secondary outcomes (1)
Ventilations
ventilations per minute over 5 minute test sequence and overall number for 5 minutes
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startSep 2008
- Primary completionSep 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiopulmonary ResuscitationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Zoll Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Paul Dorian, MD, FRCPC, Principal investigator, Unity Health TorontoNatalie Wong, MD, FRCPC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361919
- Sponsor's protocol ID
- PLP 6534
- Acronym
- BLSPilot
- Status last verified
- May 2019
- First submitted
- 3 Aug 2010
- Last updated
- 15 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No sharing is planned
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of a Simplified Method for CPR Training of Medical Professionals: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01361919
- Acronym / sponsor ID
- BLSPilot / PLP 6534
- Conditions
- Cardiopulmonary Resuscitation
- Keywords
- compressions, quality, teaching method, feedback, CPR performance, Cardiopulmonary resuscitation (CPR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Zoll Medical Corporation
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 May 2011 (estimated)
- Results
- Posted 15 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to compare three methods of teaching medical and nursing students basic life saving skills. The standard method will teach students how to push on the chest and to analyze the heart rhythm using a regular monitor. The newer approach will teach the same skills but use a special heart monitor that provides both visual and verbal reminders. The third approach will combine both the standard and newer approaches to teaching. Our study would like to find out the better way to teach these skills and to create a standard way to grade how well students perform. This study will measure how deep and how fast the students push on the manikin's chest in a certain amount of time. Other goals include measuring how well the students use the heart monitor to deliver shocks and analyze the heart rhythm, how many breaths per minute they give, how long their hands are off the manikin and how well they think they performed overall.
Detailed description
The survival rates for out-of-hospital cardiac arrest (OCA) remain low (approximately 5%), despite recent advances in advanced cardiac life support (ACLS) and expansion of emergency medical services (EMS) across Ontario and Canada. Although the survival rates for in-hospital cardiac arrest are higher, less than 20% ultimately survive to discharge. One of the most important determinants of survival from cardiac arrest appears to be initiation of early and effective chest compressions. Yet the quality of cardiopulmonary resuscitation (CPR) and basic life support (BLS) delivered by first responders is often poor. CPR appears to be delivered inconsistently, incompletely and with undue delays in both the in-hospital and out-of-hospital setting. In an effort to improve cardiac arrest outcomes, focus has recently shifted to methods for training in CPR. Optimal BLS (involving chest compressions, artificial ventilation, and the use of an automated external defibrillator where available) is difficult to perform well, to teach, and to retain at a high skill level. Most BLS training programs use hands-on instruction, printed materials, and global assessment for evaluation, which to date have not been shown to impact on the quality of the CPR/BLS provided. Guidelines for BLS have changed substantially since 2005, and the efficacy of the teaching programs aimed at laypersons or primary providers of emergency care is unknown. A potential result of these limitations in the teaching, training, evaluation, and retention of BLS skills is that CPR continues to be poorly performed both by trained lay rescuers and professional caregivers.
New technologies incorporated into commercially available defibrillators may help in the training and evaluation of BLS skills. These devices allow measurement of chest compression depth and rate and ventilation frequency with continuous real-time feedback provided to the caregiver by means of an on-screen icon, which is a simple visual measure of integrated CPR efficacy, as well as verbal prompts to encourage best performance. Electronic information is stored in the defibrillator for subsequent off-line analysis which can be used to provide additional visual feedback. Perhaps most importantly, these tools provide a quantitative measure of the quality of the resuscitation effort by integrating the various aspects of CPR performance.
To date no clinical study has assessed if such tools would facilitate both the training and testing of CPR skills using the new 2005 cardiac arrest guidelines. To answer this question, the investigators propose to conduct a clinical trial involving medical and nursing students (considered "lay rescuers"), randomized to three different teaching strategies. The advantage of this population is that they are relatively easy to access and in addition, provide a homogeneous population with similarities in background, education, motivation and personal expectations. They also represent a large proportion of individuals who, in time, will be exposed to and will respond to in-hospital cardiac arrests. By using medical and nursing students who are still in the formative stages of their concepts of allied health members, the investigators hope to provide an opportunity for them to work with, about and from each other.
The control group will receive standard teaching of BLS according to the ILCOR 2005 Guidelines, including appropriate chest compression rate, depth, and chest recoil with minimization of "hands-off" time, appropriate ventilation, and use of a standard defibrillator (Zoll M series). The first intervention group will receive training supplemented by the use of a novel defibrillator (Zoll R Series) which allows for real-time continuous feedback with both visual and audio prompts to optimize CPR performance, as well as additional off-line review of details of chest compressions (including rate and depth), "hands-off" time (time spent not doing chest compressions), and therapy sequencing. The second intervention group will receive training with the novel defibrillator (Zoll R Series) but will be tested with the standard defibrillator (Zoll M series).
Two hundred and forty consenting students will be randomly assigned to the standard training ("control") group, or to training and testing using the advanced feedback features ("intervention group 1"), or to training using the advanced feedback features but tested using the standard defibrillator ("intervention group 2"), in groups of 2. After a two hour training period all participants will be tested for approximately 5 minutes. Students in the control and intervention groups will be randomized to three groups: R-Series, R series and M series or M-Series defibrillators and tested using a scenario similar to the training session.
The primary outcome is total CPR fraction (percentage of time doing chest compressions during the scenario). Secondary outcomes are CPR fraction per minute, average rate of compressions per minute, total recorded hands-off time, average depth of compressions, and the average integrated "icon fullness" as an approximation of cardiac output. Overall performance in terms of integrated psychomotor skills, reasons for hands-off time, appropriate versus inappropriate use of the AED in terms of rhythm analysis, shock delivery and study participant self-assessment of performance will also be measured. After a 3 month period, students will be re-tested using the same testing scenario to assess for skill retention. No further BLS training will be given prior to retesting.
This will be the first study to evaluate objectively and in a controlled manner the usefulness of these new technologies in the teaching, learning and evaluation of CPR/BLS.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Feedback During CPR Training and Testing | Experimental | Procedure: Feedback During CPR Training and Testing, Procedure: Feedback during CPR Training Not TestingA "feedback" defibrillator (ZOLL R series) will be used at teaching, immediate testing and 12 week (retention) testing. A simulation manikin with an attached accelerometer pad on its sternum will be used to collect CPR performance data. Subjects will be told to perform compressions on top of the accelerometer pad and will be taught to use and follow the audio and visual feedback to optimize their CPR performance. After training, the raw data collected by the accelerometer will be used as a demonstration and training tool, to correct the subjects' performance by visually demonstrating the difference between ideal and suboptimal CPR performance. Testing will be carried out with the use of a "feedback" defibrillator. |
| Feedback during CPR Training Not Testing | Active comparator | Procedure: Feedback During CPR Training and TestingA "feedback" defibrillator will be used for teaching, with a standard no "feedback" defibrillator used at immediate and 12 week (retention) testing to assess if the techniques the students' learned during training are transferable to devices without "feedback". In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. |
| No Feedback Group | Placebo comparator | Procedure: No Feedback GroupA standard no "feedback" defibrillator (ZOLL M series) will be used for teaching, immediate testing and 12 week (retention) testing. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. During the test, subjects will be informed that data on their performance will be recorded but they will not be told how this will occur. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- medical or nursing students aged >= 18
Key exclusion criteria (2 listed)
- unwilling to sign consent, or
- unable to return in 3 months time for follow up
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 |
|---|---|---|
| Feedback During CPR Training and TestingStudents in this group will receive training in BLS skills according to the 2005 AHA/ILCOR guidelines, using the ZOLL R Series™ defibrillator with an attached accelerometer pad that will be placed on the sternum of the manikin and visible to the user. Participants will be taught to use and follow the audio and visual feedback provided by the accelerometer and defibrillator to optimize their CPR performance (depth, rate, and minimal "hands-off" time). After the simulated cardiac arrest scenario, a data card containing the raw data collected from the accelerometer and defibrillator will be downloaded onto a laptop and used as a demonstration and training tool. | Procedure or surgery | Feedback During CPR Training and Testing, Feedback during CPR Training Not Testing |
| No Feedback GroupAlso: simulation CPR trainingA standard no "feedback" defibrillator (ZOLL M series) will be used for teaching, immediate testing and 12 week (retention) testing. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. During the test, subjects will be informed that data on their performance will be recorded but they will not be told how this will occur. | Procedure or surgery | No Feedback Group |
| Feedback during CPR Training Not TestingAlso: Feedback during simulation testingStudents in this group will be tested using a five minute basic vfib arrest scenario and an R-series defibrillator and told to perform compressions on top of the accelerometer pad. The hexagonal icon will be visible but no prompting on its usage will be delivered during testing. | Procedure or surgery | Feedback During CPR Training and Testing |
Primary outcome
CPR Depth
Time frame: baseline
Depth of chest compressions measured in millimeters
CPR Rate
Time frame: baseline
rate of chest compression per minute
1 secondary outcome
Ventilations
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No sharing is planned
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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.
Paul Dorian, MD, FRCPC principal investigator
Unity Health Toronto
Natalie Wong, MD, FRCPC principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback During CPR Training and Testing, No Feedback Group and Feedback during CPR Training Not Testing in people with Cardiopulmonary Resuscitation, run by Unity Health Toronto at 1 site in Canada.
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 1 inclusion and 2 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 15 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 1 site in Canada. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 15 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CPR Depth (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2019.