UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023671 |
|---|---|
| Receipt number | R000027264 |
| Scientific Title | Comparison of the Pentax-AWS Airway Scope and Airway Exchange Catheter for tracheal tube exchange in infants -A manikin study- |
| Date of disclosure of the study information | 2016/08/18 |
| Last modified on | 2016/08/18 16:50:48 |
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Basic information
Public title
Comparison of the Pentax-AWS Airway Scope and Airway Exchange Catheter for tracheal tube exchange in infants -A manikin study-
Acronym
Utility of the Airway Scope for tracheal tube exchange
Scientific Title
Comparison of the Pentax-AWS Airway Scope and Airway Exchange Catheter for tracheal tube exchange in infants -A manikin study-
Scientific Title:Acronym
Utility of the Airway Scope for tracheal tube exchange
Region
| Japan |
Condition
Condition
Mechanical ventilation
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the utility of Airway Scope usage for tracheal tube exchange
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine whether tracheal tube exchange time using the Airway Scope is shorter than that using the Airway Exchange Catheter
Key secondary outcomes
To determine whether the Airway Scope reduced non-ventilation time compared with the Airway Exchange Catheter technique
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Anesthesiologists in our hospital
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Tampo |
Organization
Asahikawa Medical University
Division name
Department of Emergency Medicine
Zip code
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido
TEL
0166-68-2852
atampo1031@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihito Tampo |
Organization
Asahikawa Medical University
Division name
Department of Emergency Medicine
Zip code
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido
TEL
0166-68-2852
Homepage URL
atampo1031@gmail.com
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 08 | Month | 18 | 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
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The time taken to visualize the vocal cords and the time taken to perform tracheal tube exchange were both shorter with the Airway Scope than with the Airway Exchange Catheter. In addition, non-ventilation time during tube exchange was significantly shorter with the Airway Scope.
Management information
Registered date
| 2016 | Year | 08 | Month | 18 | Day |
Last modified on
| 2016 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027264
