UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004532 |
|---|---|
| Receipt number | 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 08:28:41 |
* 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
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
e.tanida@machida-city-hp.jp
Sponsor or person
Institute
Machida municipal hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005408
