UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004532
Receipt No. R000005408
Scientific Title The study of the usefulness of a continuous suction on the lower pharynx during percutaneous endoscopic gastrostomy for preventing from aspiration.
Date of disclosure of the study information 2010/12/01
Last modified on 2013/11/11

* 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 The study of the usefulness of a continuous suction on the lower pharynx during percutaneous endoscopic gastrostomy for preventing from aspiration.
Acronym The study of the continuous suction on the lower pharynx during PEG
Scientific Title The study of the usefulness of a continuous suction on the lower pharynx during percutaneous endoscopic gastrostomy for preventing from aspiration.
Scientific Title:Acronym The study of the continuous suction on the lower pharynx during PEG
Region
Japan

Condition
Condition Dysphagia
Classification by specialty
Medicine in general Gastroenterology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study the usefulness of the continuous suction on the lower pharynx for preventing from aspiration during percutaneous endoscopic gastrostomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes of the chest CT, body temperature, white blood counts, C reactive protein, SpO2 and conciousness level.
Key secondary outcomes The suction volume of saliva during PEG.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Continuous suction on the lower pharynx
Interventions/Control_2 Suction on the pharynx when it needs.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are performed PEG in our hospital.
Key exclusion criteria The patinets who were performed tracheotomy.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoyoshi Izumi
Organization Machida municipal hospital
Division name Gastroenterology
Zip code
Address 2-15-41, Asahi-machi, Machida-city, Tokyo, Japan
TEL 042-722-2230
Email e.tanida@machida-city-hp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Emiko Tanida
Organization Machida municipal hospital
Division name Gastroenterology
Zip code
Address 2-15-41, Asahi-machi, Machida-city, Tokyo, Japan
TEL 042-722-2230
Homepage URL
Email e.tanida@machida-city-hp.jp

Sponsor
Institute Machida municipal hospital
Institute
Department

Funding Source
Organization Machida municipal hospital
Organization
Division
Category of Funding Organization Self funding
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 町田市民病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2010 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded
2013 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 11 Month 09 Day
Last modified on
2013 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005408

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.