UMIN-CTR Clinical Trial

Basic information
Public title	Is it possible to achieve high quality CPR by mass training? A randomized manikin study
Acronym	Is it possible to achieve high quality CPR by mass training? A randomized manikin study
Scientific Title	Is it possible to achieve high quality CPR by mass training? A randomized manikin study
Scientific Title:Acronym	Is it possible to achieve high quality CPR by mass training? A randomized manikin study
Region	Europe

Condition
Condition	CPR quality after mass training in comparison to standard BLS training
Classification by specialty	Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of our study was to assess the quality of chest compressions after Mass Training in comparison to standard BLS training.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint was the difference in the percentage of compressions with correct depth (50-60 mm) between the groups.
Key secondary outcomes	Secondary endpoints were the differences in the percentage of correctly released compressions, in the percentage of compressions with correct hand position and in the number of compressions per minute between the groups.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver Other
Interventions/Control_1	Control Group: standard BLS course (1-h theory and 4-h practice) on a classic BLS manikin with an instructor:attendee:manikin ratio of 1:5:1
Interventions/Control_2	Intervention Group: Mass Training course (30-mins theory and 45-mins practice) on a low-budget inflatable manikin with an instructor:attendee:manikin ratio of 1:15:15
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Lay people over 16 years old and with no previous training in CPR were eligible for randomization.
Key exclusion criteria	Lay people previously trained in CPR.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Enrico Middle name Last name Contri
Organization	Pavia nel Cuore
Division name	Pavia nel Cuore
Zip code	27100
Address	Via Campari 58/B
TEL	+3903821726480
Email	info@pavianelcuore.it

Public contact
Name of contact person	1st name Enrico Middle name Last name Baldi
Organization	Pavia nel Cuore
Division name	Pavia nel Cuore
Zip code	27038
Address	Via Sauro 34, 27038 Robbio (PV), Italy
TEL	+393293556062
Homepage URL
Email	enrico.baldi@pavianelcuore.it

Sponsor
Institute	Pavia nel Cuore
Institute
Department

Funding Source
Organization	Pavia nel Cuore, Robbio nel Cuore
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	Robbio nel Cuore
Name of secondary funder(s)

IRB Contact (For public release)
Organization	CE San Matteo
Address	Viale Golgi 19
Tel	03825011
Email	comitatobioetica@smatteo.pv.it

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 03 Month 01 Day
Date of IRB	2015 Year 03 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2019 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 08 Month 20 Day
Last modified on	2019 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021669