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

January 20, 2017 updated by: Ottawa Hospital Research Institute

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:

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • The Ottawa Hospital, Civic Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female aged 55 or older
  2. Must score 3 or less on the validated Clinical Frailty Scale 11
  3. Able to follow instructions in English or French

  4. Able to understand and give informed consent

    Exclusion Criteria:

  5. Musculoskeletal condition precluding the ability to kneel down and perform CPR (e.g. severe arthritis, cast, wrist sprain, recent joint surgery)
  6. 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)
  7. Pulmonary condition precluding the ability to perform a moderate effort (e.g. emphysema, severe asthma, pneumonia)
  8. Active communicable disease e.g. tuberculosis, meningitis, gastro enteritis, hepatitis A or B, herpes simplex)
  9. Inability to perform chest compressions at appropriate rate and depth despite positive feedback during one to two-minute practice session

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CPR 30:2
30 chest compressions to 2 ventilations
Procedure: bystander CPR using 30:2 ratio vs 15:2 ratio
Participants will use 2 CPR techniques with different chest compression to ventilation ratios
Active Comparator: CPR 15:2
15 chest compressions to 2 ventilations
Procedure: bystander CPR using 30:2 ratio vs 15:2 ratio
Participants will use 2 CPR techniques with different chest compression to ventilation ratios

What is the study measuring?

Primary Outcome Measures

Outcome Measure
CPR quality

Secondary Outcome Measures

Outcome Measure
Heart Rate Blood Pressure Borg Rating of Perceived Exertion Scale Lactate levels

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Christian Vaillancourt, MD, Msc,, Ottawa Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 23, 2006

First Submitted That Met QC Criteria

September 23, 2006

First Posted (Estimate)

September 26, 2006

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006347-01H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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