UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042239 |
|---|---|
| Receipt number | R000048226 |
| Scientific Title | The protective effect of powered air purifying respirators during chest compressions: A simulation study |
| Date of disclosure of the study information | 2020/10/27 |
| Last modified on | 2021/10/27 13:56:49 |
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Basic information
Public title
The protective effect of powered air purifying respirators during chest compressions: A simulation study
Acronym
The protective effect of powered air purifying respirators during chest compressions: A simulation study
Scientific Title
The protective effect of powered air purifying respirators during chest compressions: A simulation study
Scientific Title:Acronym
The protective effect of powered air purifying respirators during chest compressions: A simulation study
Region
| Japan |
Condition
Condition
Health care workers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the protective effect of powered air purifying respirators (PAPRs) during chest compressions.
To clarify the safe and suitable use of PAPRs in the care of COVID-19 patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is a ratio of the any failure of protection (simulated workplace protecting factor; SWPF < 500) during sessions of chest compression.
Adequacy of respirator fit was represented by the fit factor (FF), which is calculated as the number of ambient particles divided by the number inside the respirator. We defined the FF during chest compression as the SWPF.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The participants wearing PAPRs perform continuous chest compressions on the manikin in 2-min sessions, while measuring SWPF in real time.
We use a Mask Fitting Tester, Model MT-05U (SIBATA Scientific Technology LTD, JAPAN) to measure the SWPF in this simulation.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Health care workers who belong to the research institution and met all the following criteria were eligible for inclusion:
1) 20 years of age or older; 2) those certified for the delivery of basic life support or advanced cardiovascular life support by the American Heart Association or Japanese Association for Acute Medicine.
Key exclusion criteria
Participants with conditions that could cause harm to their health due to continuous chest compressions on the manikin such as pregnant, having asthma, coronary heart disease, and musculoskeletal diseases.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | Goto |
Organization
Nagoya University Hospital
Division name
Department of Emergency and Critical Care
Zip code
466-8560
Address
65 Tsurumai, Showa, Nagoya, Aichi, Japan
TEL
052-744-2659
gotoyu@med.nagya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukari |
| Middle name | |
| Last name | Goto |
Organization
Nagoya University Hospital
Division name
Department of Emergency and Critical Care
Zip code
466-8560
Address
65 Tsurumai, Showa, Nagoya, Aichi, Japan
TEL
052-744-2659
Homepage URL
gotoyu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
NAKATANI FOUNDATION for advancement of measuring technologies in biomedical engineering
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital Institutional Review Board
Address
65 Tsurumai, Showa, Nagoya, Aichi, Japan
Tel
052-741-2111
ethics@med.nagoya-u.ac.jp
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
| 2020 | Year | 10 | Month | 27 | 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
54
Results
Overall, 78% (n=42) of the participants failed (SWPF < 500) at least one of the three sessions of chest compression. The ratio of the failure of protection (SWPF < 500) was 72% (n=39), 56% (n=30), and 46% (n=25) in the first, second, and third sessions, respectively.
Results date posted
| 2021 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Fifty-four participants were included in this study. Overall, the median age was 34 (IQR 27-41) years, 39% were female, and the median body mass index was 21.4 (IQR 20.0-24.1). Participants were employed as doctors (57%), nurses (33%), and others (9%).
Participant flow
Adverse events
Outcome measures
The primary outcome was the ratio of any failure of protection (SWPF < 500) during the chest compression sessions.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 26 | Day |
Last modified on
| 2021 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048226
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