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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000029575
Receipt No. R000033789
Scientific Title an assessment of the DAMS TuLip-i in fiberoptic endotracheal intubation
Date of disclosure of the study information 2017/10/17
Last modified on 2019/04/18

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Basic information
Public title an assessment of the DAMS TuLip-i in fiberoptic endotracheal intubation
Acronym an assessment of the DAMS TuLip-i in fiberoptic endotracheal intubation
Scientific Title an assessment of the DAMS TuLip-i in fiberoptic endotracheal intubation
Scientific Title:Acronym an assessment of the DAMS TuLip-i in fiberoptic endotracheal intubation
Region
Japan

Condition
Condition airway management in general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 assessment of the DAMS TuLip-i which is an assisting airway for fiberoptic intubation and bag valve mask ventilation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes glottic viewing of the fiberscope at the induction of general anesthesia
Key secondary outcomes success rate of bag valve mask ventilation without assistive tecnique,
time to insert fiberscope to the trachea

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria patients scheduled for elective surgery requiring general anesthesia
Key exclusion criteria loosening teeth, full stomach, and patients thought to be contraindication
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanobu Uesugi
Organization kawanishi city hospital
Division name anesthesia
Zip code
Address 5-21-1, higashi uneno, kawanishi, Hyogo, Japan
TEL +81-72-794-2321
Email uesugi5082@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takanobu Uesugi
Organization kawanishi city hospital
Division name department of anesthesia
Zip code
Address 5-21-1, higashi uneno, kawanishi, Hyogo, Japan
TEL +81-72-794-2321
Homepage URL
Email ikyoku@kawanishi-city-hospital.com

Sponsor
Institute kawanishi city hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 10 Month 17 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
2013 Year 09 Month 01 Day
Date of IRB
2017 Year 10 Month 17 Day
Anticipated trial start date
2017 Year 10 Month 17 Day
Last follow-up date
2017 Year 10 Month 17 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 10 Month 17 Day
Date analysis concluded

Other
Other related information assessing the effectiveness of the DAMS TuLip-i for bag valve mask ventilation and recording the glottic view of bronchoscope via the device at the induction of general anesthesia

Management information
Registered date
2017 Year 10 Month 16 Day
Last modified on
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033789

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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