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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011368
Receipt No. 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

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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
Email

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
Email matsudanak@yahoo.co.jp

Sponsor
Institute Medical Center Narita Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013310

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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