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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016942
Receipt No. R000019665
Scientific Title Predictive Pressure Loss due to Compression of Tracheal Tube in Nasal Cavity in Nasotracheal Intubation: Simulation Study
Date of disclosure of the study information 2015/03/30
Last modified on 2016/09/26

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Basic information
Public title Predictive Pressure Loss due to Compression of Tracheal Tube in Nasal Cavity in Nasotracheal Intubation: Simulation Study
Acronym Pressure Loss due to Compression of Tracheal Tube in Nasal Cavity
Scientific Title Predictive Pressure Loss due to Compression of Tracheal Tube in Nasal Cavity in Nasotracheal Intubation: Simulation Study
Scientific Title:Acronym Pressure Loss due to Compression of Tracheal Tube in Nasal Cavity
Region
Japan

Condition
Condition oral and maxillofacial disease
Classification by specialty
Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The application of a small sized tracheal tube to nasotracheal intubation and/or partial constriction of the tube in nasal passageway may associate with considerable increase of airway resistance. The aim of this study is to clarify the effect of partial constriction of tracheal tube to airway resistance by physical simulation model and the rheological simulation model on the basis of aeromechanics.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes inner diameter of tracheal tube in the nasal cavity
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 Inside dial caliper gauge is used for measurement of inner diameter of the tube. Following ventilation with 100% oxygen at completion of surgery, a minor axis of the tube in the nasal cavity was measured within one minute by inserting the caliper gauge legs into the tube with 5 cm.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ASA physical status I or II patients, older than 20 yr, who undergo elective oral and maxillofacial surgery in which nasotracheal intubation is required for surgical access.
Key exclusion criteria severe obesity, expected difficult intubation, history of taking anticoagulant drugs, frequent nasal obstruction, bleeding diathesis, and evident deviated nasal septum or deformity of nasal concha on computed tomography (CT) images
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Takasugi
Organization Kindai University Faculty of Medicine
Division name Department of Anesthesiology
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama 589-8511, Japan
TEL 072-366-0221
Email dzc01654@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Takasugi
Organization Kindai University Faculty of Medicine
Division name Department of Anesthesiology
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama 589-8511, Japan
TEL 072-366-0221
Homepage URL
Email dzc01654@nifty.com

Sponsor
Institute Department of Anesthesiology, Kindai University Faculty of Medicine
Institute
Department

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 近畿大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 30 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 Completed
Date of protocol fixation
2015 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 20 Day
Last follow-up date
2015 Year 04 Month 30 Day
Date of closure to data entry
2015 Year 04 Month 30 Day
Date trial data considered complete
2015 Year 08 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 27 Day
Last modified on
2016 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019665

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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