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

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 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


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

Value
https://center6.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