UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014385 |
|---|---|
| Receipt number | R000016689 |
| Scientific Title | Measurement of Endotracheal Tube Movement by bronchofiberscope with Changes of Head Position |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2016/01/27 21:00:18 |
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Basic information
Public title
Measurement of Endotracheal Tube Movement by bronchofiberscope with Changes of Head Position
Acronym
Measurement of Endotracheal Tube Movement with Changes of Head Position Changes
Scientific Title
Measurement of Endotracheal Tube Movement by bronchofiberscope with Changes of Head Position
Scientific Title:Acronym
Measurement of Endotracheal Tube Movement with Changes of Head Position Changes
Region
| Japan |
Condition
Condition
Adult patient with scheduled surgery
Classification by specialty
| Surgery in general | Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reduce airway problems due to endotracheal tube movement from changes in head position
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The distance of three sections from the upper incisor to the (i) carina; (ii) tracheal tube tip; and (iii) vocal cords are measured by bronchofiberscope and analyzed.
Key secondary outcomes
Base
Study type
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Measure endotracheal tube movement with five changes of head position
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects: Grade 1 or 2 Physical Status of the ASA (American Society of Anesthesiologists) of Adult Patients with Scheduled Surgery
Key exclusion criteria
(1)Conscious patients with limited cervical range of motion (2)Patients with prior history of cervical vertebrae surgery (3)Patients with a history of laryngopharynx or lung surgery with possible deformity or degeneration (4)Patients with many missing teeth causing unstable endotracheal tube fixation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimiyasu Sato |
Organization
Nihon Koukan Hospital
Division name
Department of Anesthesia
Zip code
Address
1-2-1 Koukandouri Kawasaki-ku Kawasaki-shi Kanagawa Japan
TEL
044-333-5591
kimisato@comet.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimiyasu Sato |
Organization
Nihon Koukan Hospital
Division name
Department of Anesthesia
Zip code
Address
1-2-1 Koukandouri Kawasaki-ku Kawasaki-shi Kanagawa Japan
TEL
044-333-5591
Homepage URL
matsudanak@yahoo.co.jp
Sponsor or person
Institute
Nihon Koukan 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
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
日本鋼管病院（神奈川県）
Nihon Koukan Hospital（Kanagawa）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | 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
| 2014 | Year | 06 | Month | 26 | Day |
Last modified on
| 2016 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016689
