UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024857 |
|---|---|
| Receipt number | R000028607 |
| Scientific Title | Comparison of the effectiveness of Laryngeal Mask Proseal and DAMS TuLip in the patients of chin-tuck position assumed halo vest fixation. |
| Date of disclosure of the study information | 2016/11/16 |
| Last modified on | 2019/04/01 10:04:56 |
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Basic information
Public title
Comparison of the effectiveness of Laryngeal Mask Proseal and DAMS TuLip in the patients of chin-tuck position assumed halo vest fixation.
Acronym
Comparison of the effectiveness of Laryngeal Mask Proseal and DAMS TuLip in the patients of chin-tuck position.
Scientific Title
Comparison of the effectiveness of Laryngeal Mask Proseal and DAMS TuLip in the patients of chin-tuck position assumed halo vest fixation.
Scientific Title:Acronym
Comparison of the effectiveness of Laryngeal Mask Proseal and DAMS TuLip in the patients of chin-tuck position.
Region
| Japan |
Condition
Condition
difficult airway
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effectiveness of Laryngeal mask proseal and DAMS TuLip, in the chin-tuck position patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Picture of the glottis through the device at the time of device insertion.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
using Laryngeal mask Proseal at the induction of the general anesthesia
Interventions/Control_2
using DAMS TuLip at the induction of the general anesthesia
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Adult patient of ASA physical status 1~3.
2.Patients that their chin will be tucked naturally when in the supine position.
Key exclusion criteria
1.Hemorrhagic diathesis in mouth or pharynx
2.Full stomach
3.Cases that the investigator decided as inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takanobu |
| Middle name | |
| Last name | Uesugi |
Organization
Kawanishi City Hospital
Division name
department of anesthesia
Zip code
666-0195
Address
5-21-1, higashiuneno, kawanishi city, Hyogo Pref., JAPAN
TEL
072-794-2321
uesugi5082@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takanobu |
| Middle name | |
| Last name | Uesugi |
Organization
Kawanishi City Hospital
Division name
department of anesthesia
Zip code
666-0195
Address
5-21-1, higashiuneno, kawanishi city, Hyogo Pref., JAPAN
TEL
072-794-2321
Homepage URL
uesugi5082@yahoo.co.jp
Sponsor or person
Institute
Kawanishi City Hospital
Institute
Department
Personal name
Funding Source
Organization
Kawanishi City Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kawanishi City Hospital
Address
5-21-1, higashiuneno, kawanishi city, Hyogo Pref., JAPAN
Tel
072-794-2321
ikyoku@kawanishi-city-hospital.com
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
市立川西病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 16 | 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
20
Results
In the initial 8 patients of the study, there were complete upper airway obstruction in 2 patients of the Proseal group.
We stopped comparing the two device and changed the protocol to single device assessment.
Results date posted
| 2019 | Year | 04 | Month | 01 | Day |
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
| 2013 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 26 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 31 | Day |
Other
Other related information
This study protocol is the capturing the image of the glottis through the two airway devices, after induction of general anesthesia in a conventional manner.
Management information
Registered date
| 2016 | Year | 11 | Month | 16 | Day |
Last modified on
| 2019 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028607
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/04/01 | FSSresults.xlsx |
