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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022914
Receipt No. 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

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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
Email 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
Email genakagawa@shikoku-cc.go.jp

Sponsor
Institute NHO Shikoku Cancer Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026404

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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