UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018603 |
|---|---|
| Receipt number | 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 11:20:43 |
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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
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
tatsuhikomasue@yahoo.co.jp
Sponsor or person
Institute
Gifu Prefectural Genereal Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021527
