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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035470
Receipt No. R000040406
Scientific Title Pharyngeal packing of the sealing effect on the pharyngolarynx.
Date of disclosure of the study information 2019/01/07
Last modified on 2019/01/07

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Basic information
Public title Pharyngeal packing of the sealing effect on the pharyngolarynx.
Acronym Subglottic irrigation for the bacteria contamination
Scientific Title Pharyngeal packing of the sealing effect on the pharyngolarynx.
Scientific Title:Acronym Subglottic irrigation for the bacteria contamination
Region
Japan

Condition
Condition Oral/Dental Disease
Classification by specialty
Anesthesiology Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effects of subglottic irrigation on the bacteria contamination
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bacterial examinations in subglottic lavage before and after surgery
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Single subglottic irrigation with saline
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ASA-Physical Status 1/2
Key exclusion criteria Upper airway infection
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Seiji Watanabe
Organization Kyushu Dental University
Division name Dental Anesthesiology
Zip code
Address 2-6-1, Manazuru, Kokurakita-ku, Kitakyushu-shi, Fukuoka
TEL 81935821131
Email r12watanabe@fa.kyu-dent.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Seiji Watanabe
Organization Kyushu Dental University
Division name Dental Anesthesiology
Zip code
Address 2-6-1, Manazuru, Kokurakita-ku, Kitakyushu-shi, Fukuoka
TEL 81935821131
Homepage URL
Email r12watanabe@fa.kyu-dent.ac.jp

Sponsor
Institute Kyushu Dental University
Institute
Department

Funding Source
Organization Kyushu Dental University
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 01 Month 07 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
2018 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 08 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
2019 Year 01 Month 07 Day
Last modified on
2019 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040406

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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