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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02940964
Other study ID # 2016/2773
Secondary ID
Status Completed
Phase N/A
First received October 17, 2016
Last updated February 12, 2017
Start date October 17, 2016
Est. completion date November 23, 2016

Study information

Verified date February 2017
Source Singapore General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date November 23, 2016
Est. primary completion date October 20, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 100 Years
Eligibility 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 Design


Intervention

Behavioral:
Count on me Singapore (COMS) CPR
Using the song as a mental metronome to guide CPR.
Standard CPR
Standard CPR with "one-and-two-and-three...." counting

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Singapore General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Average compression rate As read by Laerdal SkillReporter Immediately after 2 min of CPR
Secondary Average depth of compression As read by Laerdal SkillReporter Immediately after 2 min of CPR
Secondary Number of incorrect hand placement alerts As read by Laerdal SkillReporter Immediately after 2 min of CPR
Secondary Number of compressions with inadequate recoil As read by Laerdal SkillReporter Immediately after 2 min of CPR
Secondary Fatigue level after a cycle of CPR of 2 minutes duration, on a 10-point scale Survey on a 10-point scale Immediately after completing both types of CPR (crossover) 2 minutes
Secondary 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 Immediately after completing both types of CPR (crossover) 2 minutes
Secondary 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 Between 7-14 days
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