Cardiac ArrestCOMSCPRNCT02940964
Evaluation of Culture-specific Popular Music as a Mental Metronome for Cardiopulmonary Resuscitation
A study testing Count on me Singapore (COMS) CPR and Standard CPR in people with Cardiac Arrest and Out-of-hospital Cardiac Arrest, run by Singapore General Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest, Out-of-hospital Cardiac Arrest
- What is being tested?
- Count on me Singapore (COMS) CPR and Standard CPR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2016to 23 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All volunteers are eligible. This mimics a real world situation where any trained member of the public can provide bystander CPR.
Who cannot join
- 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)
About this study
Official title: Evaluation of Culture-specific Popular Music as a Mental Metronome for Cardiopulmonary Resuscitation: A Randomized Crossover Trial
Abstract
Introduction
Read more
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.
- Conditions
- Cardiac Arrest, Out-of-hospital Cardiac Arrest
- Being tested
- Count on me Singapore (COMS) CPR, Standard CPR
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Count on me Singapore (COMS) CPRBehavioural
Also called COMSCPR
Using the song as a mental metronome to guide CPR.
Standard CPRBehavioural
Standard CPR with "one-and-two-and-three...." counting
| Study group | Role | What they receive |
|---|---|---|
| COMSCPR first | Experimental | 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. Receives: Behavioral: Count on me Singapore (COMS) CPR |
| Standard CPR first | Active comparator | 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. Receives: Behavioral: Standard CPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average compression rate
As read by Laerdal SkillReporter
Measured: Immediately after 2 min of CPR
Secondary outcomes (6)
Average depth of compression
As read by Laerdal SkillReporter
Measured: Immediately after 2 min of CPR
Number of incorrect hand placement alerts
As read by Laerdal SkillReporter
Measured: Immediately after 2 min of CPR
Number of compressions with inadequate recoil
As read by Laerdal SkillReporter
Measured: Immediately after 2 min of CPR
Fatigue level after a cycle of CPR of 2 minutes duration, on a 10-point scale
Survey on a 10-point scale
Measured: 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
Survey on a 5-point scale
Measured: 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
As read by Laerdal SkillReporter
Measured: Between 7-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start17 Oct 2016
- Primary completion20 Oct 2016
- Study completion23 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940964
- Sponsor's protocol ID
- 2016/2773
- Acronym
- COMSCPR
- Status last verified
- Feb 2017
- First submitted
- 17 Oct 2016
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Culture-specific Popular Music as a Mental Metronome for Cardiopulmonary Resuscitation: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT02940964
- Acronym / sponsor ID
- COMSCPR / 2016/2773
- Conditions
- Cardiac Arrest, Out-of-hospital Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 17 Oct 2016 (actual)
- Primary completion
- 20 Oct 2016 (actual)
- Study completion
- 23 Nov 2016 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COMSCPR first | Experimental | Behavioral: Count on me Singapore (COMS) CPRGroup 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. |
| Standard CPR first | Active comparator | Behavioral: Standard CPRGroup 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. |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All volunteers are eligible. This mimics a real world situation where any trained member of the public can provide bystander CPR.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Count on me Singapore (COMS) CPRAlso: COMSCPRUsing the song as a mental metronome to guide CPR. | Behavioural | COMSCPR first |
| Standard CPRStandard CPR with "one-and-two-and-three...." counting | Behavioural | Standard CPR first |
Primary outcome
Average compression rate
Time frame: Immediately after 2 min of CPR
As read by Laerdal SkillReporter
6 secondary outcomes
Average depth of compression
Time frame: Immediately after 2 min of CPR
Number of incorrect hand placement alerts
Time frame: Immediately after 2 min of CPR
Number of compressions with inadequate recoil
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Count on me Singapore (COMS) CPR and Standard CPR in people with Cardiac Arrest and Out-of-hospital Cardiac Arrest, run by Singapore General Hospital.
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 1 inclusion and 3 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 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average compression rate (time frame: Immediately after 2 min of CPR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2017.