Bystander Fatigue and CPR Quality Using Continuous Compressions Versus 30:2 Compressions to Ventilation

April 13, 2018 updated by: Ottawa Hospital Research Institute

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:

  1. The achieved frequency and depth of chest compressions, and
  2. Participant rating of their perceived level of exertion.

STUDY HYPOTHESIS

In a population aged 55 or greater, the new CPR recommendations will lead to:

  1. less frequent and shallower chest compressions over the 5-minute study period; and
  2. higher rating of perceived level of exertion when compared to the 2005 30:2 CPR ratio.

Study Overview

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:

  1. The achieved frequency and depth of chest compressions, and
  2. 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 Type

Interventional

Enrollment (Actual)

63

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

    • Ontario
      • Ottawa, Ontario, Canada, K1Y4E9
        • 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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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 followed by cross-over to CPR with Continuous Compressions
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.
Other Names:
  • cardiopulmonary resuscitation
Active Comparator: CPR with Continuous Compressions
Continuous Chest Compressions without ventilation followed by CPR 30:2 (30 chest compressions to 2 ventilations)
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.
Other Names:
  • cardiopulmonary resuscitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPR Quality
Time Frame: 5 minutes
Count of compressions at a depth over 2 inches
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: Assessed immediately before and after 5 minutes of CPR
Assessed immediately before and after 5 minutes of CPR
Blood Pressure
Time Frame: Assessed immediately before and after 5 minutes of CPR
Mean arterial pressure (mmHg)
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
The Borg Rating of Perceived Exertion scale ranges from 6-20, where a score of 6 is associated with the least fatigue
Assessed immediately before and after 5 minutes of CPR

Collaborators and Investigators

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

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.

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

July 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 13, 2011

First Submitted That Met QC Criteria

July 18, 2011

First Posted (Estimate)

July 19, 2011

Study Record Updates

Last Update Posted (Actual)

November 15, 2018

Last Update Submitted That Met QC Criteria

April 13, 2018

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2011358-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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