UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008575 |
|---|---|
| Receipt number | R000010073 |
| Scientific Title | Usefulness of a continuous suction mouthpiece during percutaneous endoscopic gastrostomy: a single-center, prospective, randomized study |
| Date of disclosure of the study information | 2012/07/30 |
| Last modified on | 2012/07/30 20:43:28 |
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Basic information
Public title
Usefulness of a continuous suction mouthpiece during percutaneous endoscopic gastrostomy: a single-center, prospective, randomized study
Acronym
Trial of Usefulness of a continuous suction mouthpiece
Scientific Title
Usefulness of a continuous suction mouthpiece during percutaneous endoscopic gastrostomy: a single-center, prospective, randomized study
Scientific Title:Acronym
Trial of Usefulness of a continuous suction mouthpiece
Region
| Japan |
Condition
Condition
Patients with brain disease, neurological disease, dementia, temporomandibular joint disorder, disuse syndrome, or a psychiatric disorder who were scheduled to undergo PEG or the exchange of a gastrostomy button or tube with endoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the usefulness and the ability of the newly developed continuous suction mouthpiece for the prevention of aspiration during percutaneous endoscopic gastrostomy by examining salivary flow and the incidence of aspiration-related events during the procedure.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The items evaluated were duration of the procedure, extent of salivary flow, frequency of saliva suction, and the number of choking episodes.
Key secondary outcomes
examination time, sedeation effect, blood blisters or any suction tube fragments in the oral cavity after use of continuous suction mouthpiece.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
July 2012 to December 2013
Interventions/Control_2
the group using of continuous suction mouthpiece: 50cases
Interventions/Control_3
the group using of the MB-142 mouthpiece (control): 50cases
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with brain disease, neurological disease, dementia, temporomandibular joint disorder, disuse syndrome, or a psychiatric disorder who were scheduled to undergo PEG or the exchange of a gastrostomy button or tube with endoscopy.
Key exclusion criteria
Patients had a history of respiratory problems that could increase the risk of complications .
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Maekita |
Organization
Wakayama Medical University
Division name
Department of Gastroenterology
Zip code
Address
811 Kimiidera, Wakayama City, Wakayama 641-0012, Japan
TEL
0734410627
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Maekita |
Organization
Wakayama Medical University
Division name
Department of Gastroenterology
Zip code
Address
811 Kimiidera, Wakayama City, Wakayama 641-0012, Japan
TEL
0734410627
Homepage URL
maekita@wakayama-med.ac.jp
Sponsor or person
Institute
Nakaya Hospital
Institute
Department
Personal name
Funding Source
Organization
Nakaya Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Wakayama Medical University
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
中谷病院（和歌山）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 30 | Day |
Last modified on
| 2012 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010073
