UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051495 |
|---|---|
| Receipt number | R000058701 |
| Scientific Title | Microbiological Studies on Nasotracheal Intubation; Differences by Disinfection Method |
| Date of disclosure of the study information | 2023/06/30 |
| Last modified on | 2023/06/30 16:34:48 |
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Basic information
Public title
(Continued) Microbiological studies related to nasotracheal intubation
Acronym
(Continued) Microbiological studies related to nasotracheal intubation
Scientific Title
Microbiological Studies on Nasotracheal Intubation; Differences by Disinfection Method
Scientific Title:Acronym
Microbiological Studies on Nasotracheal Intubation; Differences by Disinfection Method
Region
| Japan |
Condition
Condition
Common Oral Surgical Diseases
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study clarify which disinfection method is suitable for nasotracheal intubation by quantifying bacteria before and after disinfection associated with different disinfection methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bacterial counts before and after disinfection caused by different disinfection methods
Key secondary outcomes
Presence or absence of epistaxis caused by different disinfection methods
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
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After induction of anesthesia, disinfect the nasal cavity of the subject with a fine cotton swab.
Interventions/Control_2
After induction of anesthesia, disinfect the nasal cavity of the subject with a thick cotton swab.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients between 20 and 70 years old undergoing general anesthesia under nasotracheal intubation in the operating room of Aichi-Gakuin University Dental Hospital
Key exclusion criteria
Patients allergic to benzalkonium chloride
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Okuda |
Organization
Aichi Gakuin University
Division name
School of Dentistrt
Zip code
464-8651
Address
2-11, Suemori-dori, Chikusa-ku,Nagoya,Aichi
TEL
052-759-2111
okudamacbookpro@gmail.com
Public contact
Name of contact person
| 1st name | Aiji |
| Middle name | |
| Last name | Sato |
Organization
Aichi Gakuin University
Division name
School of Dentistry
Zip code
465-8651
Address
2-11, Suemori-dori, Chikusa-ku,Nagoya,Aichi
TEL
052-759-2111
Homepage URL
bokuaiji@dpc.agu.ac.jp
Sponsor or person
Institute
Aichi Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Aichi Gakuin University
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
Ethics Committee, School of Dentistry, Aichi-Gakuin University
Address
1-100, Kusmoto-cho, Chikusa-ku, Nagoya, Aichi
Tel
052-751-2561
akiyon@dpc.agu.ac.jp
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
| 2023 | Year | 06 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058701
| Research Plan | |
|---|---|
| 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 |
