UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018735 |
|---|---|
| Receipt number | R000021672 |
| Scientific Title | The Simplified Predictive Laryngeal mask airway Difficulty Score: a new score for difficult airway assessment. |
| Date of disclosure of the study information | 2015/08/20 |
| Last modified on | 2015/08/21 15:37:42 |
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Basic information
Public title
The Simplified Predictive Laryngeal mask airway Difficulty Score: a new score for difficult airway assessment.
Acronym
The Simplified Predictive Laryngeal mask airway Difficulty Score: a new score for difficult airway assessment.
Scientific Title
The Simplified Predictive Laryngeal mask airway Difficulty Score: a new score for difficult airway assessment.
Scientific Title:Acronym
The Simplified Predictive Laryngeal mask airway Difficulty Score: a new score for difficult airway assessment.
Region
| Japan |
Condition
Condition
Patient under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are a few reports of prediction for difficult ventilation via a supragllotic airways. If we identified the risk factors, anesthesiologist is able to change the plan for airway management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The score for difficult ventilation via a supraglottic airways
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patient with American sociaty anesthesiologist 1 or 2
Key exclusion criteria
Patient with emergency operation
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhisa Okuda |
Organization
Dokkyomedical university Koshigaya Hospital
Division name
Department of anesthesiology
Zip code
Address
2-1-50 Minamikoshigaya Koshigaya city Saitama Japan
TEL
0489651111
s-tomo@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Saito |
Organization
Dokkyomedical university Koshigaya Hospital
Division name
Department of anesthesiology
Zip code
Address
2-1-50 Minamikoshigaya Koshigaya city Saitama Japan
TEL
048-965-1111
Homepage URL
s-tomo@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyomedical university Koshigaya Hospital
Institute
Department
Personal name
Funding Source
Organization
Dokkyomedical university Koshigaya Hospital
Organization
Division
Category of Funding Organization
Other
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 | 08 | Month | 20 | 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
Sex, Thyromental distance limited neck movement, age
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
Preinitiation
Date of protocol fixation
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 02 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects patient: Patient aged above 18 years old with American society anesthesiologist grade I or II. Emegency operation and laparoscopic surgery are excepted in this study.
Management information
Registered date
| 2015 | Year | 08 | Month | 20 | Day |
Last modified on
| 2015 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021672
