UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029645 |
|---|---|
| Receipt number | R000033873 |
| Scientific Title | Microbiological study on nasotracheal intubation |
| Date of disclosure of the study information | 2017/10/21 |
| Last modified on | 2018/04/23 15:36:21 |
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Basic information
Public title
Microbiological study on nasotracheal intubation
Acronym
Microbiological study on nasotracheal intubation
Scientific Title
Microbiological study on nasotracheal intubation
Scientific Title:Acronym
Microbiological study on nasotracheal intubation
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will clarify which disinfectant should be used for hygienic nasotracheal intubation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of bacteria after disinfection
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Use povidone-iodine as a disinfectant
Interventions/Control_2
Use benzalkonium chloride as a disinfectant
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy Adults
Key exclusion criteria
Patient with allergy of povidone-iodine or benzalkonium
chloride
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Harada |
Organization
Aichi Gakuin University School of Dentistry
Division name
Department of Anesthesiology
Zip code
Address
2-11 Suemoridori, Chikusa-ku, Nagoya, Aichi, 464-8651, Japan
TEL
052-759-2111
hjun@dpc.agu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aiji Sato(Boku) |
Organization
Aichi Gakuin University School of Dentistry
Division name
Department of Anesthesiology
Zip code
Address
2-11 Suemoridori, Chikusa-ku, Nagoya, Aichi, 464-8651, Japan
TEL
052-759-2111
Homepage URL
bokuaiji@dpc.agu.ac.jp
Sponsor or person
Institute
Aichi Gakuin University School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Aichi Gakuin University School of Dentistry
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
愛知学院大学歯学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 21 | 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
| 2017 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 23 | 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
| 2017 | Year | 10 | Month | 21 | Day |
Last modified on
| 2018 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033873
