- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02940964
Evaluation of Culture-specific Popular Music as a Mental Metronome for Cardiopulmonary Resuscitation (COMSCPR)
Evaluation of Culture-specific Popular Music as a Mental Metronome for Cardiopulmonary Resuscitation: A Randomized Crossover Trial
Abstract
Introduction
Bystander cardiopulmonary resuscitation (CPR) can more than double the patient's chance of survival in Out-of-hospital cardiac arrest (OHCA). In Singapore, bystander CPR rate was low. Recent studies have proposed and validated the use of popular songs as aids in performing CPR. These songs may not be widely known when applied to a different population, and further, may lose popularity over time. "Count on me Singapore" (COMS) is believed to be known to over 90% of the Singapore population. Pilot data indicated that CPR performed using COMS as a mental metronome (COMSCPR) can achieve guideline-compliant rate of chest compression with lower fatigue level than CPR guided by the conventional "one-and-two-three-and" (Standard CPR). The investigators hypothesize that COMSCPR is non-inferior to Standard CPR in achieving guideline-compliant rate of chest compression.
Methodology
The investigators planned a prospective, randomized, crossover non-inferiority trial comparing COMS CPR and Standard CPR. 80 eligible volunteers will be recruited from a convenience sample of camp personnel from a military training camp. After a 15 minutes familiarization session, they will be randomized into two groups (A and B). Group A will proceed to perform one cycle (two minutes) of Standard CPR, while group B will proceed to perform one cycle of COMS CPR. participants will cross over to perform one cycle of the other method of CPR. After completing this second cycle, a survey form will be administered. The Laerdal SkillReporter will be used to measure the CPR performed. After a 7-14 days interval, participants will be recalled to attend a test scenario. Statistical analysis will be used to compare the two arms.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All volunteers are eligible. This mimics a real world situation where any trained member of the public can provide bystander CPR.
Exclusion Criteria:
- Lack of informed consent
- Existing medical conditions that may cause danger to the participant (e.g. cardiac conditions or musculoskeletal injuries)
- Recent CPR course attended (within past one month)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: COMSCPR first
Group A will proceed to perform one cycle (two minutes) of COMSCPR.
After taking a fifteen minute rest, participants will cross over to perform one cycle of the other method of CPR.
|
Using the song as a mental metronome to guide CPR.
Other Names:
|
ACTIVE_COMPARATOR: Standard CPR first
Group A will proceed to perform one cycle (two minutes) of Standard CPR.
After taking a fifteen minute rest, participants will cross over to perform one cycle of the other method of CPR.
|
Standard CPR with "one-and-two-and-three...." counting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average compression rate
Time Frame: Immediately after 2 min of CPR
|
As read by Laerdal SkillReporter
|
Immediately after 2 min of CPR
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average depth of compression
Time Frame: Immediately after 2 min of CPR
|
As read by Laerdal SkillReporter
|
Immediately after 2 min of CPR
|
Number of incorrect hand placement alerts
Time Frame: Immediately after 2 min of CPR
|
As read by Laerdal SkillReporter
|
Immediately after 2 min of CPR
|
Number of compressions with inadequate recoil
Time Frame: Immediately after 2 min of CPR
|
As read by Laerdal SkillReporter
|
Immediately after 2 min of CPR
|
Fatigue level after a cycle of CPR of 2 minutes duration, on a 10-point scale
Time Frame: Immediately after completing both types of CPR (crossover) 2 minutes
|
Survey on a 10-point scale
|
Immediately after completing both types of CPR (crossover) 2 minutes
|
Satisfaction of CPR provider in terms of ease of learning, fatigue and overall effectiveness assessed with a Survey on a 5-point scale
Time Frame: Immediately after completing both types of CPR (crossover) 2 minutes
|
Survey on a 5-point scale
|
Immediately after completing both types of CPR (crossover) 2 minutes
|
Ability to retain compression rate using COMS CPR after a 7-14 day interval with no additional prompting in between
Time Frame: Between 7-14 days
|
As read by Laerdal SkillReporter
|
Between 7-14 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/2773
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Cardiac Arrest
-
Australian and New Zealand Intensive Care Research...Ambulance VictoriaNot yet recruitingOut of Hospital Cardiac Arrest
-
University Medical Centre MariborRecruiting
-
IRCCS Policlinico S. MatteoOslo University Hospital; University of the Basque Country (UPV/EHU); The Hospital...CompletedOut-Of-Hospital Cardiac ArrestItaly, Norway, Spain
-
Lithuanian University of Health SciencesEgle Vaitkaitiene; Dinas Vaitkaitis; Asta Krikscionaitiene; Ilona Kajokaite; Nerijus...CompletedOut-Of-Hospital Cardiac ArrestLithuania
-
Ceric SàrlAbbottTerminatedOut of Hospital Cardiac ArrestBelgium, France, Serbia
-
Prehospital Center, Region ZealandCompletedOut-Of-Hospital Cardiac Arrest
-
Karolinska InstitutetSwedish Heart Lung FoundationCompletedCardiac Arrest | Out of Hospital Cardiac ArrestSweden
-
Karolinska InstitutetVastra Gotaland Region; SOS Alarm Sverige AB; Everdrone AB; Aviation capacity resources... and other collaboratorsCompleted
-
Brno University HospitalTerminatedOut-Of-Hospital Cardiac ArrestCzechia
-
SRINIVAS RAMAKAUnknownOut-Of-Hospital Cardiac ArrestIndia
Clinical Trials on Count on me Singapore (COMS) CPR
-
Linnaeus UniversityKarolinska Institutet; Uppsala University; Stockholm University; KTH Royal Institute... and other collaboratorsRecruitingWell-being in Elementary School Children | Mental Health in Elementary School Children | Work-related Stress in Teachers | Academic Performance in Elementary School ChildrenSweden