UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The patients management of the tracheal stoma retainer
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	GENKI NAKAGAWA
Organization	NHO Shikoku Cancer Center
Division name	Nursing
Address	160 Minamiumemoto Matsuyama City Ehime
TEL	089-999-1111
Email	genakagawa@shikoku-cc.go.jp

Public contact
Name of contact person	GENKI NAKAGAWA
Organization	NHO Shikoku Cancer Center
Division name	Nursing
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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