UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034119 |
|---|---|
| Receipt number | 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 | 2021/05/21 15:41:47 |
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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 | Obstetrics 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
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
konotori-konotori@gaia.eonet.ne.jp
Sponsor or person
Institute
Toyooka public hospitals' association
Institute
Department
Personal name
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
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
| Delay expected |
Results Delay Reason
For the spread of COVID-19 infection
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
| 2018 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 30 | Day |
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
| 2021 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038628
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
