UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022914 |
|---|---|
| Receipt number | R000026404 |
| Scientific Title | The patients management of the tracheal stoma retainer |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2016/06/27 16:55:30 |
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Basic information
Public title
The patients management of the tracheal stoma retainer
Acronym
The patients management of the tracheal stoma retainer
Scientific Title
The patients management of the tracheal stoma retainer
Scientific Title:Acronym
The patients management of the tracheal stoma retainer
Region
| Japan |
Condition
Condition
Head and Neck Cancer
Classification by specialty
| Oto-rhino-laryngology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The single time use tracheotomy tube is made clear about tube management practice of the patient who left while inserting.
Basic objectives2
Others
Basic objectives -Others
The single time use tracheotomy tube is made clear by an interview about tube management practice of the patient who left while inserting.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.The patient can understand the instruction from a medical person and can deal with an accidental occurrence phenomenon after the tracheotomy.
2.While the patient lives under daily life can perform the withdrawal prevention of retina and occlude prevention.
3.It is necessary for not only a right method but also the verboten to instruct the instruction contents.
4.Because a withdrawal of retina is generated in the scene which a medical person does not predict after a discharge I provide information to a family with a patient and it is necessary to rouse attention. In addition I examine staying out for trial.
5.When the self-insertion of the cashless cannula is difficult the patient of the distant place plans cooperation to have you insert it at other hospitals and I intervene so that a patient and a family leave the hospital with confidence.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient who could get consent of a H study among the patient who left while inserting RETINA R for 5 years until August, 22-H August, 27
Key exclusion criteria
The patient for whom interview implementation is difficult
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | GENKI NAKAGAWA |
Organization
NHO Shikoku Cancer Center
Division name
Nursing
Zip code
Address
160 Minamiumemoto Matsuyama City Ehime
TEL
089-999-1111
genakagawa@shikoku-cc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | GENKI NAKAGAWA |
Organization
NHO Shikoku Cancer Center
Division name
Nursing
Zip code
Address
160 Minamiumemoto Matsuyama City Ehime
TEL
089-999-1111
Homepage URL
genakagawa@shikoku-cc.go.jp
Sponsor or person
Institute
NHO Shikoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
NHO Shikoku Cancer Center
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
| 2016 | Year | 07 | Month | 01 | 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
| 2015 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The 70th Annual Meeting of Japanese Society ofNational Medical Searvices
Management information
Registered date
| 2016 | Year | 06 | Month | 27 | Day |
Last modified on
| 2016 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026404
