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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018603
Receipt No. R000021527
Scientific Title Efficacy and safety of tracheal intubation for infants and children with AirwayScope
Date of disclosure of the study information 2015/08/10
Last modified on 2020/02/12

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Basic information
Public title Efficacy and safety of tracheal intubation for infants and children with AirwayScope
Acronym Tracheal intubation for infants with AirwayScope
Scientific Title Efficacy and safety of tracheal intubation for infants and children with AirwayScope
Scientific Title:Acronym Tracheal intubation for infants with AirwayScope
Region
Japan

Condition
Condition Infants undergoing tracheal intubation in the operating rooms
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To idenfify a success rate and durations of laryngoscopy attempt for tracheal intubation with AirwayScope, changes of hemodynamic parameter and SpO2 during the intubation in each infant group with different category of comorbid congenital heart diseases.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Success for tracheal intubation.
Developing any complications.
Key secondary outcomes Duration of laryngoscopy attempt for tracheal intubation.
Number of attempts for tracheal intubation.
Changes in blood pressure, heart rate, and SpO2.

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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Tracheal intubation for infants with AirwayScope in the operating rooms. Data for each patient are collected during the intubation.
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

Not applicable
Age-upper limit
1 years-old >
Gender Male and Female
Key inclusion criteria Infants aged under 1 years undergoing tracheal intubation in the operating rooms in Gifu Prefectural General Medical Center.
Key exclusion criteria Patients without informed consent.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Tatsuhiko
Middle name
Last name Masue
Organization Gifu Prefectural General Medical Center
Division name Department of Anesthesiology
Zip code 500-8717
Address 4-6-1 Noishiki, Gifu 500-8717, Japan
TEL 058-246-1111ext.8088
Email tatsuhikomasue@yahoo.co.jp

Public contact
Name of contact person
1st name Tatsuhiko
Middle name
Last name Masue
Organization Gifu Prefectural General Medical Center
Division name Department of Anesthsiology
Zip code 500-8717
Address 4-6-1 Noishiki, Gifu 500-8717, Japan
TEL 058-246-1111ext.8088
Homepage URL
Email tatsuhikomasue@yahoo.co.jp

Sponsor
Institute Gifu Prefectural Genereal Medical Center
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 Gifu Prefectural General Medical Center
Address 4-6-1 Noishiki, Gifu 500-8717 Japan
Tel 0582461111
Email tatsuhikomasue@yahoo.co.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 岐阜県総合医療センター(岐阜県)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 10 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
2013 Year 12 Month 25 Day
Date of IRB
2013 Year 12 Month 25 Day
Anticipated trial start date
2015 Year 08 Month 10 Day
Last follow-up date
2026 Year 12 Month 31 Day
Date of closure to data entry
2026 Year 12 Month 31 Day
Date trial data considered complete
2026 Year 12 Month 31 Day
Date analysis concluded
2027 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 08 Day
Last modified on
2020 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021527

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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