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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034119
Receipt No. R000038628
Scientific Title Development of auxiliary devices for improving bag mask ventilation difficulty (DMV) during systemic anesthesia introduction and resuscitation
Date of disclosure of the study information 2018/09/13
Last modified on 2019/03/18

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Basic information
Public title Development of auxiliary devices for improving bag mask ventilation difficulty (DMV) during systemic anesthesia introduction and resuscitation
Acronym Development of auxiliary instruments to improve bag mask ventilation difficulty (DMV)
Scientific Title Development of auxiliary devices for improving bag mask ventilation difficulty (DMV) during systemic anesthesia introduction and resuscitation
Scientific Title:Acronym Development of auxiliary instruments to improve bag mask ventilation difficulty (DMV)
Region
Japan

Condition
Condition Patients undergoing general anesthesia
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Breast surgery Obsterics and gynecology Pediatrics
Dermatology Oto-rhino-laryngology Orthopedics
Urology Anesthesiology Oral surgery
Neurosurgery Cardiovascular surgery Plastic surgery
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Improvement of bag mask ventilation difficulty
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ventilation volume during bag mask ventilation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Intervention period 1 day
Interventions/Control_2 Mouthpiece wearing
Interventions/Control_3 Tongue elevation
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Persons without severe complications
Key exclusion criteria Those who can not ventilate with a mask
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Kono
Organization Toyooka public hospital
Division name Department of Anesthesiology
Zip code 668-8501
Address 1094 Tobera Toyooka City, Hyogo, Japan
TEL 0796226111
Email konotori-konotori@gaia.eonet.ne.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Kono
Organization Toyooka public hospital
Division name Department of Anesthesiology
Zip code 668-8501
Address 1094 Tobera Toyooka City, Hyogo, Japan
TEL 0796226111
Homepage URL
Email konotori-konotori@gaia.eonet.ne.jp

Sponsor
Institute Toyooka public hospitals' association
Institute
Department

Funding Source
Organization Toyooka public hospitals' association
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Toyooka public hospitals' association
Address 1094 Tobera Toyooka City, Hyogo, Japan
Tel 0796226111
Email konotori-konotori@gaia.eonet.ne.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 公立豊岡病院

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 13 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 Open public recruiting
Date of protocol fixation
2018 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 13 Day
Last modified on
2019 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038628

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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