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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011327
Receipt No. R000013275
Scientific Title Navigability of tracheal tubes through the nasal cavity during nasotracheal intubation
Date of disclosure of the study information 2013/07/31
Last modified on 2013/07/31

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Basic information
Public title Navigability of tracheal tubes through the nasal cavity during nasotracheal intubation
Acronym Navigability of tracheal tubes
Scientific Title Navigability of tracheal tubes through the nasal cavity during nasotracheal intubation
Scientific Title:Acronym Navigability of tracheal tubes
Region
Japan

Condition
Condition patients scheduled to undergo oral and maxillofacial surgery requiring nasotracheal intubation
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to clarify which direction of the bevel and tip of the tube can enhance navigability and reduce epistaxis during nasotracheal intubation, using four kinds of tracheal tubes with different bevel and tip directions.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We supposed that if the bevel of the tube is faced to the posterior nasopharyngeal wall and the distal tip is headed to the oropharynx, the tube might pass smoothly through the nasopharynx and nasal bleeding might be prevented.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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
Device,equipment
Interventions/Control_1 the direction of the bevel of the nasotracheal tube
Interventions/Control_2 the direction of the tip of the nasotracheal tube
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
16 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria the patient was scheduled to undergo oral or maxillofacial surgery requiring nasotracheal intubation
Key exclusion criteria patients with a history of nasal surgery, trauma, recurrent epistaxis, hemopathy, or coagulopathy were excluded from the study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuna Sugiyama
Organization Kagoshima University Medical and Dental Hospital
Division name Dental Anesthsia
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima
TEL 099-275-6280
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuna Sugiyama
Organization Kagoshima University Medical and Dental Hospital
Division name Dental Anesthsia
Zip code
Address
TEL 099-275-6280
Homepage URL
Email sugi@dent.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University Medical and Dental Hospital
Institute
Department

Funding Source
Organization Kagoshima University
Organization
Division
Category of Funding Organization
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
2013 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2008 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 31 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
2013 Year 07 Month 31 Day
Last modified on
2013 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013275

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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