UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027806 |
|---|---|
| Receipt number | R000031861 |
| Scientific Title | The confirmation of a tracheal tube placement by using ultrasonography (combined with a gastric tube) |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2020/04/02 13:10:17 |
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Basic information
Public title
The confirmation of a tracheal tube placement by using ultrasonography (combined with a gastric tube)
Acronym
The confirmation of a tracheal tube placement by using ultrasonography (combined with a gastric tube)
Scientific Title
The confirmation of a tracheal tube placement by using ultrasonography (combined with a gastric tube)
Scientific Title:Acronym
The confirmation of a tracheal tube placement by using ultrasonography (combined with a gastric tube)
Region
| Japan |
Condition
Condition
tracheal intubation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the confirmation of a tracheal tube placement by using ultrasound
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To measure the sensitivity and the specificity of the confirmation of a tracheal tube placement by using ultrasonography
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
ultrasonography( a tracheal tube)
Interventions/Control_2
ultrasonography( a gastric tube)
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
| 0 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
elective surjery
scheduled for tracheal intubation
obtained informed consent
Key exclusion criteria
expected difficult airway
anatomic abnormalities
full stomach
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tanaka Hiroshi |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology&Critical care
Zip code
Address
midorigaokahigashi 2-1-1, asahikawa
TEL
0166-68-2583
rxe06152@nifty.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yokoyama |
Organization
Asahikawa Medical University
Division name
Reserch Ethics Committee
Zip code
Address
midorigaokahigashi 2-1-1, asahikawa
TEL
0166-68-2187
Homepage URL
rs-kk.g@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
Organization
Division
Category of Funding Organization
Government offices of other countries
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
| 2017 | Year | 07 | Month | 01 | 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
| 2016 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 19 | Day |
Last modified on
| 2020 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031861
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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