UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019861 |
|---|---|
| Receipt number | R000022926 |
| Scientific Title | Single blind test comparing blade size 3 with 4,the Mcgrath videolaryngoscope in intubating adult patients. |
| Date of disclosure of the study information | 2015/11/19 |
| Last modified on | 2016/04/28 12:50:10 |
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Basic information
Public title
Single blind test comparing blade size 3 with 4,the Mcgrath videolaryngoscope in intubating adult patients.
Acronym
Single blind test comparing blade size 3 with 4,the Mcgrath videolaryngoscope in intubating adult patients.
Scientific Title
Single blind test comparing blade size 3 with 4,the Mcgrath videolaryngoscope in intubating adult patients.
Scientific Title:Acronym
Single blind test comparing blade size 3 with 4,the Mcgrath videolaryngoscope in intubating adult patients.
Region
| Japan |
Condition
Condition
Intubating adult patients
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The study of appropriate blade size in Mcgrath videolaryngoscope.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time taken for succesful intubation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Group1 is selected Mcgrath blade3. Defind as term from when the Mcgrath videolaryngoscope is inserted into the participant's mouth until end-tidal CO2 is detected.
Interventions/Control_2
Group2 is selected Mcgrath blade4.Defind as term from when the Mcgrath videolaryngoscope is inserted into the participant's mouth until end-tidal CO2 is detected.
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
Participant aged>18yr,undergoing elective surgery,whose anaesthesia plan included routine orotracheal intubation under general anaesthesia.
Key exclusion criteria
Presence of any other predictors of difficult intubation(inter-incisor distance<3cm,chin-thyromental distance<6cm,reduced neck extension and tooth mobility etc),cervical spine instability or risk of pulmonary aspiration.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | tomohiko murata |
Organization
seichokai fuchu hospital
Division name
department anesthesiology
Zip code
Address
1-10-17 hikomachi izumi,osaka 594-0076 japan
TEL
0725-43-1234
t_murata@seichokai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | masanobu mori |
Organization
seichokai fuchu hospital
Division name
department anesthesiology
Zip code
Address
1-10-17 hikomachi izumi,osaka 594-0076 japan
TEL
0725-43-1234
Homepage URL
mas_mori@seichokai.or.jp
Sponsor or person
Institute
seichokai fuchu hospital
Institute
Department
Personal name
Funding Source
Organization
none
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 | 11 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 19 | Day |
Last modified on
| 2016 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022926
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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