UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016942 |
|---|---|
| Receipt number | 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 09:54:54 |
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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
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
dzc01654@nifty.com
Sponsor or person
Institute
Department of Anesthesiology, Kindai University Faculty of Medicine
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019665
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
