UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040284
Receipt No. R000045961
Scientific Title A study on the effect of bevel orientation of nasal tracheal tube on epistaxis
Date of disclosure of the study information 2020/05/08
Last modified on 2020/11/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A study on the effect of bevel orientation of nasal tracheal tube on epistaxis
Acronym A study on the effect of bevel orientation of nasal tracheal tube on epistaxis
Scientific Title A study on the effect of bevel orientation of nasal tracheal tube on epistaxis
Scientific Title:Acronym A study on the effect of bevel orientation of nasal tracheal tube on epistaxis
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Anesthesiology Oral surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We compare whether changing the bevel on the tip of the intubation tube make a difference in epistaxis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Presence of epistaxis
Key secondary outcomes Severity of epistaxi
Number of trials
Nasal passage time
Intubation time

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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
Maneuver
Interventions/Control_1 Turn the bevel of the nasotracheal tube to the left or right.
Interventions/Control_2 Turn the bevel of the nasotracheal tube to the superior.
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

Not applicable
Gender Male and Female
Key inclusion criteria Healthy adult
Key exclusion criteria History of nasal surgery
Recurrent epistaxis
Blood dyscrasias or coagulopathy
Target sample size 130

Research contact person
Name of lead principal investigator
1st name Takuya
Middle name
Last name Funayama
Organization Tokyo Medical and Dental University Dental Hospital
Division name Dental Anesthesia
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5549
Email funaanph@tmd.ac.jp

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Funayama
Organization Tokyo Medical and Dental University Dental Hospital
Division name Dental Anesthesia
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5549
Homepage URL
Email funaanph@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University Dental Hospital
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University Dental Hospital
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 Tokyo Medical and Dental University Dental Hospital Institutional Review Board
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel 03-5803-5404
Email d-hyoka.adm@tmd.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

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 08 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
2020 Year 03 Month 01 Day
Date of IRB
2020 Year 09 Month 11 Day
Anticipated trial start date
2020 Year 05 Month 08 Day
Last follow-up date
2025 Year 03 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
2020 Year 05 Month 01 Day
Last modified on
2020 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045961

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.