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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026447
Receipt No. R000030386
Scientific Title Study of proper position of tracheal tube at tracheotomy
Date of disclosure of the study information 2017/03/08
Last modified on 2018/09/11

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Basic information
Public title Study of proper position of tracheal tube at tracheotomy
Acronym Study of proper position of tracheal tube at tracheotomy
Scientific Title Study of proper position of tracheal tube at tracheotomy
Scientific Title:Acronym Study of proper position of tracheal tube at tracheotomy
Region
Japan

Condition
Condition Patient with tracheotomy
Classification by specialty
Pneumology Oto-rhino-laryngology Anesthesiology
Oral surgery Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 If tracheostomy is performed after endotracheal intubation, ventilation may be difficult due to breakage of the tracheal tube and cuff. Measure and examine the distance about position change of the tracheal tube tip when changing the position of the head after tracheal intubation and for surgical posture.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Distance from the tracheal bifurcation to the end of the tracheal tube after intubation and posture transformation
Key secondary outcomes Patient background (gender, height, weight, BMI, current medical history (disease name), internal medicine, chest radiograph): Comparison the relationship with tube size.

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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patient scheduled to undergo reconstructive surgery to manage general anesthesia by tracheostomy
Patients between 20 and 90 years old
Patients with prior written consent
Key exclusion criteria Patients with advanced heart (obvious heart failure and arrhythmia) disorder
Serious respiratory disease patients
Unable to communicate
Patient who other research doctor deems inappropriate
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsukamoto Masanori
Organization Kyushu university hospital
Division name Department of dental anesthesiology
Zip code
Address Higashi-ku, Fukuoka Maidashi 3-1-1
TEL 092-642-6480
Email hyamanaka@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name kamoto Masanori
Organization Kyushu university
Division name Department of dental anesthesiology
Zip code
Address Higashi-ku, Fukuoka Maidashi 3-1-1
TEL 092-642-6480
Homepage URL
Email hyamanaka@dent.kyushu-u.ac.jp

Sponsor
Institute Kyushu university
Institute
Department

Funding Source
Organization Kyushu university
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 08 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
2016 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 21 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information no special instruction

Management information
Registered date
2017 Year 03 Month 07 Day
Last modified on
2018 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030386

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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