UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011368 |
|---|---|
| Receipt number | R000013310 |
| Scientific Title | Assessment of Endotracheal Tube Movements with Changes of Head Position |
| Date of disclosure of the study information | 2013/08/03 |
| Last modified on | 2013/12/24 20:34:12 |
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Basic information
Public title
Assessment of Endotracheal Tube Movements with Changes of Head Position
Acronym
Analysis of Endotracheal Tube Movement with Head Position Changes due to Protrusion or Retraction Positions
Scientific Title
Assessment of Endotracheal Tube Movements with Changes of Head Position
Scientific Title:Acronym
Analysis of Endotracheal Tube Movement with Head Position Changes due to Protrusion or Retraction Positions
Region
| Japan |
Condition
Condition
Adult patient with scheduled digestive tract surgery
Classification by specialty
| Surgery in general | 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 were measured by bronchofiberscope and analyzed.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
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 Digestive Tract 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
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nakagawa Kiyotaka |
Organization
Kawaguchi Municipal Medical Center
Division name
Department of Anesthesia
Zip code
Address
180 Nishi-Araijyuku, Kawaguchi, Saitama, Japan
TEL
048-287-2525
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nakagawa Kiyotaka |
Organization
Kawaguchi Municipal Medical Center
Division name
Department of Anesthesia
Zip code
Address
180 Nishi-Araijyuku, Kawaguchi, Saitama, Japan
TEL
048-287-2525
Homepage URL
matsudanak@yahoo.co.jp
Sponsor or person
Institute
Medical Center Narita 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
Medical Center Narita Hospital
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
総合医療センター 成田病院(千葉県)
Medical Center Narita Hospital（Chiba）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 03 | 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
Endotracheal tube moved with head position changes due to protrusion and retraction positions
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
Terminated
Date of protocol fixation
| 2012 | Year | 11 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 18 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
A non-randomized prospectic study
Management information
Registered date
| 2013 | Year | 08 | Month | 03 | Day |
Last modified on
| 2013 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013310
