UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026447 |
|---|---|
| Receipt number | 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 15:36:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hyamanaka@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030386
