UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040284
Receipt number 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 2021/11/01 14:00:19

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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 or person

Institute

Tokyo Medical and Dental University Dental Hospital

Institute

Department

Personal name



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

130

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

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

2021 Year 11 Month 01 Day



Link to view the page

Value
https://center6.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
2022/01/18 D2020-014datarepository.xlsx