UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017851 |
|---|---|
| Receipt number | R000020687 |
| Scientific Title | Real-time visual feedback during training improves lay people's CPR quality: a randomized controlled manikin study |
| Date of disclosure of the study information | 2015/06/09 |
| Last modified on | 2015/06/09 23:55:54 |
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Basic information
Public title
Real-time visual feedback during training improves lay people's CPR quality: a randomized controlled manikin study
Acronym
Real-time visual feedback during training improves lay people's CPR quality: a randomized controlled manikin study
Scientific Title
Real-time visual feedback during training improves lay people's CPR quality: a randomized controlled manikin study
Scientific Title:Acronym
Real-time visual feedback during training improves lay people's CPR quality: a randomized controlled manikin study
Region
| Europe |
Condition
Condition
CPR quality improvement with the use of CPR feedback devices during training
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of our study is to verify if the use of CPR feedback devices improves lay people CPR quality after a CPR training course and if the quality reached is influenced by the amount of time spent training with them.
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) among 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, in the number of compressions per minute and in the Total CPR Score among the groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Control (Course 0): simple BLS-D course without any feedback
Interventions/Control_2
First intervention: BLS-D course with 1 minute training with real-time visual feedback
manikin
Interventions/Control_3
Second intervention: BLS-D course with 10 minutes training with real-time visual feedback
manikin
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
| 18 | years-old | < |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Lay people over 18 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
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Enrico Baldi |
Organization
Pavia nel Cuore
Division name
Pavia nel Cuore
Zip code
Address
Via Campari 58/B
TEL
+3903821726480
info@pavianelcuore.it
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Enrico Baldi |
Organization
Pavia nel Cuore
Division name
Pavia nel Cuore
Zip code
Address
Via Sauro 34, 27038 Robbio (PV), Italy
TEL
+393293556062
Homepage URL
enrico.baldi@pavianelcuore.it
Sponsor or person
Institute
Pavia nel Cuore
Institute
Department
Personal name
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
Address
Tel
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 | 06 | Month | 09 | 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
Comparing group 0 vs group 10 and group 0 vs group 1 there was a significant improvement in the percentage of compressions with correct depth (gr.0 vs gr.10, p=0.022 and gr.0 vs gr.1, p=0.005), in the percentage of compressions with complete chest recoil (both p<0.001), in the percentage of compressions with correct hand position (p=0.002 and p<0.001 respectively) and in Total CPR score (both p<0.001) in the groups in which the feedback was used. Furthermore, there were no statistically significant differences for all the parameters between group 1 and group 10.
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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 09 | Day |
Last modified on
| 2015 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020687
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
