UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036120
Receipt number R000041148
Scientific Title Comparison between conventional nasal intubation and Rhinoscope-guided nasotracheal intubation
Date of disclosure of the study information 2019/03/07
Last modified on 2019/03/07 21:24:22

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Basic information

Public title

Comparison between conventional nasal intubation and Rhinoscope-guided nasotracheal intubation

Acronym

Comparison between conventional nasal intubation and Rhinoscope-guided nasotracheal intubation

Scientific Title

Comparison between conventional nasal intubation and Rhinoscope-guided nasotracheal intubation

Scientific Title:Acronym

Comparison between conventional nasal intubation and Rhinoscope-guided nasotracheal intubation

Region

Japan


Condition

Condition

Patients scheduled to undergo elective surgery requireing asleep nasotracheal intubation

Classification by specialty

Anesthesiology Oral surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Performing different methods of nasal intubation, we will compare whether there will be a difference in nasal bleeding or postoperative sore throat.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Degree of nasal bleeding
Degree of sore throat
Degree of resistance in nasal passage

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

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Rhinoscope-guided nasotracheal intubation

Interventions/Control_2

Blind nasal passage without any device.

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

Patients undergoing general anesthesia

Key exclusion criteria

bleeding disorder
abnormal nasal cavity

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Chiaki Nemoto

Organization

Ohara general hospital

Division name

Department of anesthesiology

Zip code


Address

6-1 Uwamachi Fukushima-city Fukushima

TEL

024-526-0300

Email

hippo_hipp0@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Midori Mogami

Organization

Ohara general hospital

Division name

Department of anesthesiology

Zip code


Address

6-1 Uwamachi Fukushima-city Fukushima

TEL

024-526-0300

Homepage URL


Email

contralt.inutaro@gmail.com


Sponsor or person

Institute

Ohara general hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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 03 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

Open public recruiting

Date of protocol fixation

2019 Year 03 Month 07 Day

Date of IRB


Anticipated trial start date

2019 Year 03 Month 07 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 03 Month 07 Day

Last modified on

2019 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041148


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name