UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016324 |
|---|---|
| Receipt number | R000018944 |
| Scientific Title | A comparison of insertion depth of pediatric cuffed endotracheal tubes determined by intubation depth marks |
| Date of disclosure of the study information | 2015/01/25 |
| Last modified on | 2018/03/23 11:41:10 |
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Basic information
Public title
A comparison of insertion depth of pediatric cuffed endotracheal tubes determined by intubation depth marks
Acronym
Appropriateness of intubation depth marks of pediatric cuffed endotracheal tubes
Scientific Title
A comparison of insertion depth of pediatric cuffed endotracheal tubes determined by intubation depth marks
Scientific Title:Acronym
Appropriateness of intubation depth marks of pediatric cuffed endotracheal tubes
Region
| Japan |
Condition
Condition
Infants and small children requring general anesthesia and postoperative chestradiography
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purposes of the present study are to reveal factors associated with optimal insertion depth of pediatric cuffed endotracheal tubes in comparison of intubation depth marks between conventional pediatric cuffed endotracheal tubes and the new one and to make a novel formula to predict optimal insertion depth of endotracheal tubes alleviating risks for intubated pediatric patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After intubation of pediatric cuffed endotracheal tubes by direct laryngoscopy and cheking by auscultation and capnography, the tip of tubes is investigated by chestradiography.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Microcuff-PET group
Interventions/Control_2
Mallinckrodt group
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
| 12 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Infants and small children requring general anesthesia and postoperative chestradiography
Key exclusion criteria
Exclusion criteria are emergency surgery, known or anticipated difficult intubation and ASA physical status >III
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teiji Sawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Anesthesiology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, japan
TEL
0752515633
anesth@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Sibasaki |
Organization
Kyoto Prefectural University of Medicine
Division name
Anesthesiology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, japan
TEL
0752515633
Homepage URL
mshiba@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
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
| 2015 | Year | 01 | Month | 25 | 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
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | 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 | 01 | Month | 24 | Day |
Last modified on
| 2018 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018944
