Cardiac ArrestNCT01397656
Bystander Fatigue and CPR Quality Using Continuous Compressions Versus 30:2 Compressions to Ventilation
A study testing CPR using 30:2 ratio and CPR using continuous compressions in people with Cardiac Arrest, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
STUDY OBJECTIVES The overall goal of this study is to compare bystander fatigue and CPR quality after 5 minutes of continuous chest compressions versus the 2005 30:2 chest compression to ventilation Resuscitation Guidelines, in a population aged 55 or greater. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- CPR using 30:2 ratio and CPR using continuous compressions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Sep 2011
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female person aged 55 or older
- Must score 3 or less on the validated Clinical Frailty Scale
- Able to follow instructions in English or French
- Able to understand and give informed consent
Who cannot join
- Musculoskeletal condition precluding the ability to kneel down and perform CPR (e.g. severe arthritis, cast, wrist sprain, recent joint surgery)
- Cardiovascular condition precluding the ability to perform a moderate effort (e.g. myocardial infarction or cardiovascular procedure in the last 3 months, recurrent angina, chest pain under investigation)
- Pulmonary condition precluding the ability to perform a moderate effort (e.g. emphysema, severe asthma, pneumonia)
- Active communicable disease (e.g. tuberculosis, meningitis, gastro enteritis, hepatitis A or B, herpes simplex)
- Inability to perform chest compressions at appropriate rate and depth despite positive feedback during one to two-minute practice session
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Bystander Fatigue and CPR Quality When Using the 2010 Continuous Chest Compression Versus the 2005 30:2 Chest Compression to Ventilation Resuscitation Guidelines for Laymen: A Randomized Crossover Trial
STUDY OBJECTIVES The overall goal of this study is to compare bystander fatigue and CPR quality after 5 minutes of continuous chest compressions versus the 2005 30:2 chest compression to ventilation Resuscitation Guidelines, in a population aged 55 or greater.
More specifically, the investigators will compare each CPR ratio with regard to:
Read more
- The achieved frequency and depth of chest compressions, and
- Participant rating of their perceived level of exertion.
STUDY HYPOTHESIS
In a population aged 55 or greater, the new CPR recommendations will lead to:
- less frequent and shallower chest compressions over the 5-minute study period; and
- higher rating of perceived level of exertion when compared to the 2005 30:2 CPR ratio.
Read the detailed description
Background: Cardiac arrest is the number one cause of mortality in the Canadian population. Out-of-hospital bystander cardiopulmonary resuscitation (CPR) is associated with a 3 to 4 fold increase in survival for cardiac arrest, but citizens are often reluctant to initiate CPR because of its mouth-to-mouth component. In an effort to increase bystander CPR rates in the community and minimize interruptions in chest compressions, the 2010 Resuscitation Guidelines changed the 2005 recommended 30:2 compression to ventilation ratio to continuous chest compressions for laymen. Although the 30:2 ratio is meant to increase survival for cardiac arrest, the ability of rescuers to deliver continuous chest compressions has never been studied. Little is known about the impact of the new recommendations on bystander fatigue and resulting CPR quality.
Objectives: The overall goal of this study is to compare bystander fatigue and CPR quality after 5 minutes continuous chest compressions versus the 2005 30:2 chest compression to ventilation Resuscitation Guidelines in a population aged 55 or greater.
More specifically, the investigators will compare each CPR ratio with regard to:
- The achieved frequency and depth of chest compressions, and
- Participants' rating of their perceived level of exertion.
Methods: The investigators will conduct a randomized cross-over trial comparing bystander fatigue and CPR quality using two different CPR ratios. Intervention: All participants will be asked to perform two 5-minute sessions of CPR on a manikin - one session using the 30:2 ratio, the other using continuous chest compressions. There will be a supervised practice session in the beginning, and resting periods in between. The order in which the sessions will be executed will be determined in a random fashion. The study population will consist of volunteers aged 55 or older, a group most susceptible to perform CPR on a real victim. The study will take place in a busy public area of The Ottawa Hospital, Civic Campus, and in senior's activity centres in Ottawa. Participants will have to score 3 or less on the validated Clinical Frailty Scale in order to participate in the study. Participants with physical limitations or disease processes precluding their ability to safely perform CPR will be excluded. Outcome measures: Information on age, gender, prior CPR training, and measure of frailty will be collected at the time of enrollment. The number, frequency, and quality of chest compressions (depth and release) will be measured during each CPR session using a Zoll cardiac monitor with the ability to measure CPR processes. Heart rate and blood pressure will be measured before and after each CPR session. The participants will be asked to rate their level of fatigue before and after each CPR session using the validated Borg Rating of Perceived Exertion scale. Sample size: The investigators hope to recruit 60 participants. Data analysis for Objective#1 will include descriptive statistics and a paired t-test with 95% confidence interval; Objective#2 will be analyzed using descriptive statistics and Wilcoxon Rank Sum test. In addition, as an exploratory analysis, the investigators also assessed the rate of change over time in the number of chest compressions performed adequately using a random coefficient model. This study protocol will be reviewed by the OHREB before implementation, and will be entered in a trial registry.
Importance of the study: Data from this study will evaluate bystander fatigue and resulting CPR quality when comparing the 2010 continuous chest compression to the 2005 30:2 chest compression to ventilation Resuscitation Guidelines. This project will improve our understanding of the physiological demands associated with the implementation of the new CPR Resuscitation Guidelines for laymen. The investigators anticipated the results from this study will be widely distributed, and will help shape the 2015 iteration of the Resuscitation Guidelines.
- Conditions
- Cardiac Arrest
- Being tested
- CPR using 30:2 ratio, CPR using continuous compressions
- Keywords
- cardiac arrest, CPR, resuscitation, fatigue, quality
- Medical subject headings
- Heart Arrest, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPR using 30:2 ratioProcedure or surgery
Also called cardiopulmonary resuscitation
Participants will begin performing CPR using a ratio of 30 compressions to 2 ventilations. Participants will then cross over to the other intervention and use continuous compressions.
CPR using continuous compressionsProcedure or surgery
Also called cardiopulmonary resuscitation
Participants will begin performing CPR using continuous chest compressions. Participants will then cross-over to the other intervention arm and perform CPR using a ratio of 30 compressions to 2 ventilations.
| Study group | Role | What they receive |
|---|---|---|
| CPR 30:2 | Active comparator | 30 chest compressions to 2 ventilations followed by cross-over to CPR with Continuous Compressions Receives: Procedure: CPR using 30:2 ratio |
| CPR with Continuous Compressions | Active comparator | Continuous Chest Compressions without ventilation followed by CPR 30:2 (30 chest compressions to 2 ventilations) Receives: Procedure: CPR using continuous compressions |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPR Quality
Count of compressions at a depth over 2 inches
Measured: 5 minutes
Secondary outcomes (3)
Heart Rate
Measured: Assessed immediately before and after 5 minutes of CPR
Blood Pressure
Mean arterial pressure (mmHg)
Measured: Assessed immediately before and after 5 minutes of CPR
Borg Rating of Perceived Exertion Scale
The Borg Rating of Perceived Exertion scale ranges from 6-20, where a score of 6 is associated with the least fatigue
Measured: Assessed immediately before and after 5 minutes of CPR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2011
- Study completionSep 2011
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.
- Publications (2)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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Vaillancourt, MD, MSc, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397656
- Sponsor's protocol ID
- 2011358-01H
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2011
- Last updated
- 15 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Vaillancourt C, Midzic I, Taljaard M, Chisamore B. Performer fatigue and CPR quality comparing 30:2 to 15:2 compression to ventilation ratios in older bystanders: A randomized crossover trial. Resuscitation. 2011 Jan;82(1):51-6. doi: 10.1016/j.resuscitation.2010.09.003. Epub 2010 Oct 14.
PubMed 20947241Liu S, Vaillancourt C, Kasaboski A, Taljaard M. Bystander fatigue and CPR quality by older bystanders: a randomized crossover trial comparing continuous chest compressions and 30:2 compressions to ventilations. CJEM. 2016 Nov;18(6):461-468. doi: 10.1017/cem.2016.373. Epub 2016 Sep 21.
PubMed 27650514
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bystander Fatigue and CPR Quality When Using the 2010 Continuous Chest Compression Versus the 2005 30:2 Chest Compression to Ventilation Resuscitation Guidelines for Laymen: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT01397656
- Acronym / sponsor ID
- 2011358-01H
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, CPR, resuscitation, fatigue, quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Posted 15 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
STUDY OBJECTIVES The overall goal of this study is to compare bystander fatigue and CPR quality after 5 minutes of continuous chest compressions versus the 2005 30:2 chest compression to ventilation Resuscitation Guidelines, in a population aged 55 or greater.
More specifically, the investigators will compare each CPR ratio with regard to:
- The achieved frequency and depth of chest compressions, and
- Participant rating of their perceived level of exertion.
STUDY HYPOTHESIS
In a population aged 55 or greater, the new CPR recommendations will lead to:
- less frequent and shallower chest compressions over the 5-minute study period; and
- higher rating of perceived level of exertion when compared to the 2005 30:2 CPR ratio.
Detailed description
Background: Cardiac arrest is the number one cause of mortality in the Canadian population. Out-of-hospital bystander cardiopulmonary resuscitation (CPR) is associated with a 3 to 4 fold increase in survival for cardiac arrest, but citizens are often reluctant to initiate CPR because of its mouth-to-mouth component. In an effort to increase bystander CPR rates in the community and minimize interruptions in chest compressions, the 2010 Resuscitation Guidelines changed the 2005 recommended 30:2 compression to ventilation ratio to continuous chest compressions for laymen. Although the 30:2 ratio is meant to increase survival for cardiac arrest, the ability of rescuers to deliver continuous chest compressions has never been studied. Little is known about the impact of the new recommendations on bystander fatigue and resulting CPR quality.
Objectives: The overall goal of this study is to compare bystander fatigue and CPR quality after 5 minutes continuous chest compressions versus the 2005 30:2 chest compression to ventilation Resuscitation Guidelines in a population aged 55 or greater.
More specifically, the investigators will compare each CPR ratio with regard to:
- The achieved frequency and depth of chest compressions, and
- Participants' rating of their perceived level of exertion.
Methods: The investigators will conduct a randomized cross-over trial comparing bystander fatigue and CPR quality using two different CPR ratios. Intervention: All participants will be asked to perform two 5-minute sessions of CPR on a manikin - one session using the 30:2 ratio, the other using continuous chest compressions. There will be a supervised practice session in the beginning, and resting periods in between. The order in which the sessions will be executed will be determined in a random fashion. The study population will consist of volunteers aged 55 or older, a group most susceptible to perform CPR on a real victim. The study will take place in a busy public area of The Ottawa Hospital, Civic Campus, and in senior's activity centres in Ottawa. Participants will have to score 3 or less on the validated Clinical Frailty Scale in order to participate in the study. Participants with physical limitations or disease processes precluding their ability to safely perform CPR will be excluded. Outcome measures: Information on age, gender, prior CPR training, and measure of frailty will be collected at the time of enrollment. The number, frequency, and quality of chest compressions (depth and release) will be measured during each CPR session using a Zoll cardiac monitor with the ability to measure CPR processes. Heart rate and blood pressure will be measured before and after each CPR session. The participants will be asked to rate their level of fatigue before and after each CPR session using the validated Borg Rating of Perceived Exertion scale. Sample size: The investigators hope to recruit 60 participants. Data analysis for Objective#1 will include descriptive statistics and a paired t-test with 95% confidence interval; Objective#2 will be analyzed using descriptive statistics and Wilcoxon Rank Sum test. In addition, as an exploratory analysis, the investigators also assessed the rate of change over time in the number of chest compressions performed adequately using a random coefficient model. This study protocol will be reviewed by the OHREB before implementation, and will be entered in a trial registry.
Importance of the study: Data from this study will evaluate bystander fatigue and resulting CPR quality when comparing the 2010 continuous chest compression to the 2005 30:2 chest compression to ventilation Resuscitation Guidelines. This project will improve our understanding of the physiological demands associated with the implementation of the new CPR Resuscitation Guidelines for laymen. The investigators anticipated the results from this study will be widely distributed, and will help shape the 2015 iteration of the Resuscitation Guidelines.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPR 30:2 | Active comparator | Procedure: CPR using 30:2 ratio30 chest compressions to 2 ventilations followed by cross-over to CPR with Continuous Compressions |
| CPR with Continuous Compressions | Active comparator | Procedure: CPR using continuous compressionsContinuous Chest Compressions without ventilation followed by CPR 30:2 (30 chest compressions to 2 ventilations) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female person aged 55 or older
- Must score 3 or less on the validated Clinical Frailty Scale
- Able to follow instructions in English or French
- Able to understand and give informed consent
Key exclusion criteria (5 listed)
- Musculoskeletal condition precluding the ability to kneel down and perform CPR (e.g. severe arthritis, cast, wrist sprain, recent joint surgery)
- Cardiovascular condition precluding the ability to perform a moderate effort (e.g. myocardial infarction or cardiovascular procedure in the last 3 months, recurrent angina, chest pain under investigation)
- Pulmonary condition precluding the ability to perform a moderate effort (e.g. emphysema, severe asthma, pneumonia)
- Active communicable disease (e.g. tuberculosis, meningitis, gastro enteritis, hepatitis A or B, herpes simplex)
- Inability to perform chest compressions at appropriate rate and depth despite positive feedback during one to two-minute practice session
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 |
|---|---|---|
| CPR using 30:2 ratioAlso: cardiopulmonary resuscitationParticipants will begin performing CPR using a ratio of 30 compressions to 2 ventilations. Participants will then cross over to the other intervention and use continuous compressions. | Procedure or surgery | CPR 30:2 |
| CPR using continuous compressionsAlso: cardiopulmonary resuscitationParticipants will begin performing CPR using continuous chest compressions. Participants will then cross-over to the other intervention arm and perform CPR using a ratio of 30 compressions to 2 ventilations. | Procedure or surgery | CPR with Continuous Compressions |
Primary outcome
CPR Quality
Time frame: 5 minutes
Count of compressions at a depth over 2 inches
3 secondary outcomes
Heart Rate
Time frame: Assessed immediately before and after 5 minutes of CPR
Blood Pressure
Time frame: Assessed immediately before and after 5 minutes of CPR
Borg Rating of Perceived Exertion Scale
Time frame: Assessed immediately before and after 5 minutes of CPR
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20947241Vaillancourt C, Midzic I, Taljaard M, Chisamore B. Performer fatigue and CPR quality comparing 30:2 to 15:2 compression to ventilation ratios in older bystanders: A randomized crossover trial. Resuscitation. 2011 Jan;82(1):51-6. doi: 10.1016/j.resuscitation.2010.09.003. Epub 2010 Oct 14.
- Results publication: PubMed 27650514Liu S, Vaillancourt C, Kasaboski A, Taljaard M. Bystander fatigue and CPR quality by older bystanders: a randomized crossover trial comparing continuous chest compressions and 30:2 compressions to ventilations. CJEM. 2016 Nov;18(6):461-468. doi: 10.1017/cem.2016.373. Epub 2016 Sep 21.
- 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.
Christian Vaillancourt, MD, MSc principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPR using 30:2 ratio and CPR using continuous compressions in people with Cardiac Arrest, run by Ottawa Hospital Research Institute 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 4 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 15 Nov 2018. 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. 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 Nov 2018). 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 Quality (time frame: 5 minutes). 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 NCT01397656, which also lists 2 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 15 Nov 2018.