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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000018732
Receipt No. R000021669
Scientific Title Is it possible to achieve high quality CPR by mass training? A randomized manikin study
Date of disclosure of the study information 2015/08/20
Last modified on 2019/08/22

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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/ctr_e/ctr_view.cgi?recptno=R000021669

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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