UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018210 |
|---|---|
| Receipt number | R000020370 |
| Scientific Title | PH evaluation of extubated tracheal tube and supraglottic device ;corrrelation with patient symptom |
| Date of disclosure of the study information | 2015/07/06 |
| Last modified on | 2016/02/13 07:30:24 |
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Basic information
Public title
PH evaluation of extubated tracheal tube and supraglottic device ;corrrelation with patient symptom
Acronym
PH evaluation of extubated tracheal tube and supraglottic device
Scientific Title
PH evaluation of extubated tracheal tube and supraglottic device ;corrrelation with patient symptom
Scientific Title:Acronym
PH evaluation of extubated tracheal tube and supraglottic device
Region
| Japan |
Condition
Condition
Patient who undergo general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of extubated tracehal tube and supraglottic device
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PH of SGD and intubation tueb
Key secondary outcomes
Operation and patient factor
correlation with patient factor
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
PH evaluation of extubated airway devices
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient who undergo general anesthesia
Key exclusion criteria
Patient who does not undergo general anesthesia
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Minami |
Organization
Osaka Medical College
Division name
Anesthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuk city
TEL
0726-84-6361
ane022@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyasu Komasawa |
Organization
Osaka Medical College
Division name
Anesthesiology
Zip code
Address
2-7Daigaku-machi, Takatsuki city
TEL
0726-84-6361
Homepage URL
ane078@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical Coolege
Institute
Department
Personal name
Funding Source
Organization
Osaka MedicalCollege
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 06 | 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
There are some number of patients who showed acid pH around the extubated tracheal tube in prone and head-down position, but not in supie or lateral positions.
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 | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 14 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 16 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
No patient showed the symptom of aspiration pneumonia.
Management information
Registered date
| 2015 | Year | 07 | Month | 06 | Day |
Last modified on
| 2016 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020370
