Bystander Fatigue and CPR Quality Using Continuous Compressions Versus 30:2 Compressions to Ventilation
Primary Purpose
Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CPR using 30:2 ratio
CPR using continuous compressions
Sponsored by
About this trial
This is an interventional other trial for Cardiac Arrest focused on measuring cardiac arrest, CPR, resuscitation, fatigue, quality
Eligibility Criteria
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
Sites / Locations
- The Ottawa Hospital, Civic Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CPR 30:2
CPR with Continuous Compressions
Arm Description
30 chest compressions to 2 ventilations followed by cross-over to CPR with Continuous Compressions
Continuous Chest Compressions without ventilation followed by CPR 30:2 (30 chest compressions to 2 ventilations)
Outcomes
Primary Outcome Measures
CPR Quality
Count of compressions at a depth over 2 inches
Secondary Outcome Measures
Heart Rate
Blood Pressure
Mean arterial pressure (mmHg)
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
Full Information
NCT ID
NCT01397656
First Posted
June 13, 2011
Last Updated
April 13, 2018
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01397656
Brief Title
Bystander Fatigue and CPR Quality Using Continuous Compressions Versus 30:2 Compressions to Ventilation
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 Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
cardiac arrest, CPR, resuscitation, fatigue, quality
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPR 30:2
Arm Type
Active Comparator
Arm Description
30 chest compressions to 2 ventilations followed by cross-over to CPR with Continuous Compressions
Arm Title
CPR with Continuous Compressions
Arm Type
Active Comparator
Arm Description
Continuous Chest Compressions without ventilation followed by CPR 30:2 (30 chest compressions to 2 ventilations)
Intervention Type
Procedure
Intervention Name(s)
CPR using 30:2 ratio
Other Intervention Name(s)
cardiopulmonary resuscitation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
CPR using continuous compressions
Other Intervention Name(s)
cardiopulmonary resuscitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
CPR Quality
Description
Count of compressions at a depth over 2 inches
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Heart Rate
Time Frame
Assessed immediately before and after 5 minutes of CPR
Title
Blood Pressure
Description
Mean arterial pressure (mmHg)
Time Frame
Assessed immediately before and after 5 minutes of CPR
Title
Borg Rating of Perceived Exertion Scale
Description
The Borg Rating of Perceived Exertion scale ranges from 6-20, where a score of 6 is associated with the least fatigue
Time Frame
Assessed immediately before and after 5 minutes of CPR
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Vaillancourt, MD, MSc
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital, Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4E9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20947241
Citation
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.
Results Reference
background
PubMed Identifier
27650514
Citation
Liu 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.
Results Reference
result
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Bystander Fatigue and CPR Quality Using Continuous Compressions Versus 30:2 Compressions to Ventilation
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