NCT02940964

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

October 17, 2016

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2016

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

3 days

First QC Date

October 17, 2016

Last Update Submit

February 12, 2017

Conditions

Cardiac ArrestOut-of-hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • Average compression rate

    As read by Laerdal SkillReporter

    Immediately after 2 min of CPR

Secondary Outcomes (6)

  • Average depth of compression

    Immediately after 2 min of CPR

  • Number of incorrect hand placement alerts

    Immediately after 2 min of CPR

  • Number of compressions with inadequate recoil

    Immediately after 2 min of CPR

  • Fatigue level after a cycle of CPR of 2 minutes duration, 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

    Immediately after completing both types of CPR (crossover) 2 minutes

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Standard CPR

Interventions

Count on me Singapore (COMS) CPRBEHAVIORAL

Using the song as a mental metronome to guide CPR.

Also known as: COMSCPR
COMSCPR first
Standard CPRBEHAVIORAL

Standard CPR with "one-and-two-and-three...." counting

Standard CPR first

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All volunteers are eligible. This mimics a real world situation where any trained member of the public can provide bystander CPR.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart ArrestOut-of-Hospital Cardiac Arrest

Interventions

Cardiopulmonary Resuscitation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ResuscitationEmergency TreatmentTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 21, 2016

Study Start

October 17, 2016

Primary Completion

October 20, 2016

Study Completion

November 23, 2016

Last Updated

February 14, 2017

Record last verified: 2017-02