UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017379 |
|---|---|
| Receipt number | R000020164 |
| Scientific Title | Comparison of the usefulness of AirwayScope with McGRATH and GlideScope during tracheal intubation in pediatrics |
| Date of disclosure of the study information | 2015/05/02 |
| Last modified on | 2016/05/30 15:04:03 |
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Basic information
Public title
Comparison of the usefulness of AirwayScope with McGRATH and GlideScope during tracheal intubation in pediatrics
Acronym
Comparison of the usefulness of AirwayScope with McGRATH and GlideScope during tracheal intubation in pediatrics
Scientific Title
Comparison of the usefulness of AirwayScope with McGRATH and GlideScope during tracheal intubation in pediatrics
Scientific Title:Acronym
Comparison of the usefulness of AirwayScope with McGRATH and GlideScope during tracheal intubation in pediatrics
Region
| Japan |
Condition
Condition
Pediatric patients whom were scheduled to operation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to decide the usefulness of tracheal intubation for pediatrics among the three tracheal device
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
successful rate of intubation, the time to tracheal intubation, comparison of blood pressure, heart rate and saturation at post-intubation with that of pre-intubation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
airway scope will be used during endotracheal intubation. Intervention will be continued for 2 days.
Interventions/Control_2
McGRATH will be used during endotracheal intubation. Intervention will be continued for 2 days.
Interventions/Control_3
Glidescope will be used during endotracheal intubation. Intervention will be continued for 2 days.
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
| 1 | years-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
pediatrics whom were scheduled to operation
Key exclusion criteria
pediatrics were complicated with athma and upper respiratory tract infection
when parents of patients refused the participation of the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsutaka Edanaga |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
edanaka@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Nakane |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
akifujito@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Sapporo Medical University School of Medicine
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
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
| 2015 | Year | 05 | Month | 02 | 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
| 2014 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 07 | 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
| 2015 | Year | 05 | Month | 01 | Day |
Last modified on
| 2016 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020164
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
