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Cardiac ArrestNCT00380757

Comparison of Bystander Fatigue and CPR Quality When Using Two Different CPR Ratios.

A study testing bystander CPR using 30:2 ratio vs 15:2 ratio in people with Cardiac Arrest, run by Ottawa Hospital Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

STUDY OBJECTIVES The overall goal of this study is to compare bystander fatigue and CPR quality after 5 minutes of the new 30:2 versus the old 15:2 chest compression to ventilation International 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?
bystander CPR using 30:2 ratio vs 15:2 ratio
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteCanada
Study dates
Jun 2006to Nov 2006
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 aged 55 or older
  • Must score 3 or less on the validated Clinical Frailty Scale 11
  • 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.

Canada1 site
  • The Ottawa Hospital, Civic Campus

    Ottawa, Ontario, K1Y 4E9

Other trials in Canada

About this study

Official title: Comparison of Bystander Fatigue and CPR Quality When Using the New 30:2 Versus the Old 15:2 Chest Compression to Ventilation International Guidelines: A Randomised Crossover Trial

STUDY OBJECTIVES The overall goal of this study is to compare bystander fatigue and CPR quality after 5 minutes of the new 30:2 versus the old 15:2 chest compression to ventilation International Resuscitation Guidelines, in a population aged 55 or greater.

More specifically, we will compare each CPR ratio with regard to:

Read more
  1. The achieved frequency and depth of chest compressions,
  2. Participant rating of their perceived level of exertion, and
  3. Resulting serum lactate levels in a subset of the participants.

STUDY HYPOTHESIS

In a population aged 55 or greater, the new 30:2 CPR ratio will lead to:

  1. less frequent and shallower chest compressions over the 5-minute study period;
  2. higher rating of perceived level of exertion; and
  3. higher serum lactate levels in a subset of participants when compared to the old 15:2 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. Any interruption in the delivery of chest compressions to cardiac arrest victims is detrimental on survival. In an effort to minimize interruptions in chest compressions, the new International Guidelines changed the long-recommended 15:2 compression to ventilation ratio to 30:2. Although the 30:2 ratio is meant to increase survival for cardiac arrest, the ability of rescuers to deliver the new CPR ratio intervention has never been studied. Little is known about the potential 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 of the new 30:2 versus the old 15:2 chest compression to ventilation International Guidelines in a population aged 55 or greater.

More specifically, we will compare each CPR ratio with regard to:

  1. The achieved frequency and depth of chest compressions,
  2. Participant rating of their perceived level of exertion, and
  3. Resulting serum lactate levels in a subset of the participants.

Methods: We 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 recording manikin - one session using the 30:2 ratio, the other using the 15:2 ratio. 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, between the cafeteria and the emergency department. 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, height, weight, 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 recording ResusciAnne manikin. Heart rate and blood pressure will be measured before and after each CPR sessions. 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. In addition, serum lactate levels will be determined before and after each CPR session in volunteers from the second group. Sample size: We hope to recruit 42 participants, among which 10 will have their lactate levels measured. Data analysis for Objective#1 and #3 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, we will perform a stepwise logistic regression analysis to control for the potential confounding effects of variables otherwise associated with bystander fatigue and CPR performance using both CPR ratio. This study protocol will receive ascent form the OHREB before implementation, and will be entered on the OHRI randomized trial registry.

Importance of the study Data from this study will evaluate bystander fatigue and resulting CPR quality when comparing the new 30:2 to the old 15:2 International Guidelines. This highly innovative project will improve our understanding of the physiological demands associated with the implementation of the new CPR International Guidelines. We anticipated the results from this study will be widely distributed, and will help shape the next iteration of the International Resuscitation Guidelines.

Conditions
Cardiac Arrest
Being tested
bystander CPR using 30:2 ratio vs 15:2 ratio
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.

  • bystander CPR using 30:2 ratio vs 15:2 ratioProcedure or surgery

    Participants will use 2 CPR techniques with different chest compression to ventilation ratios

Study groups in NCT00380757
Study groupRoleWhat they receive
CPR 30:2Active comparator30 chest compressions to 2 ventilations
Receives: Procedure: bystander CPR using 30:2 ratio vs 15:2 ratio
CPR 15:2Active comparator15 chest compressions to 2 ventilations
Receives: Procedure: bystander CPR using 30:2 ratio vs 15:2 ratio

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CPR Quality

    Number of adequate chest compressions per minute

    Measured: over a 5 minute period

Secondary outcomes (1)
  1. Borg Rating of Perceived Exertion Blood Pressure Borg Rating of Perceived Exertion Scale

    Measures of bystander fatigue measured using the Borg's Scale for Rating of Perceived Exertion (range 6-20) measured at baseline, following first CPR sequence, before beginning second sequence and at end of second CPR sequence. Lower values represent light perceived exertion, and higher values represent higher perceived exertion. Values reported are the difference between the baseline Borg Scale measured before beginning each CPR sequence and the Borg Scale following 5 minutes of each CPR sequence.

    Measured: After 5 minutes of 15:2 CPR or 30:2 CPR

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionJul 2006
  4. Study completionNov 2006

Resources

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
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00380757
Sponsor's protocol ID
2006347-01H
Status last verified
Apr 2025
First submitted
23 Sep 2006
Last updated
15 Apr 2025
Data monitoring committee
No

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 20947241

Questions about this trial

What is this clinical trial studying?

A study testing bystander CPR using 30:2 ratio vs 15:2 ratio 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 Apr 2025. 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 Apr 2025). 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: over a 5 minute period). 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 NCT00380757, which also lists 1 linked publication.

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 Apr 2025.

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Clinical Trial NCT00380757 | AzTrials