UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of proper position of tracheal tube at tracheotomy
Title of the study (Brief title)	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	Tsukamoto Masanori
Organization	Kyushu university hospital
Division name	Department of dental anesthesiology
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	kamoto Masanori
Organization	Kyushu university
Division name	Department of dental anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000030386