UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032214 |
|---|---|
| Receipt number | R000036721 |
| Scientific Title | clinical evaluation of videolaryngoscopes |
| Date of disclosure of the study information | 2018/04/13 |
| Last modified on | 2021/06/21 09:48:47 |
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Basic information
Public title
clinical evaluation of videolaryngoscopes
Acronym
clinical evaluation of videolaryngoscopes
Scientific Title
clinical evaluation of videolaryngoscopes
Scientific Title:Acronym
clinical evaluation of videolaryngoscopes
Region
| Japan |
Condition
Condition
thoracic surgeries entailing double-lumen tube placement
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Recently, different types of video laryngoscopes have been reported for use in double-lumen tube intubation. However, the advantages and disadvantages between them remain undetermined for DLT intubation. This study aimed to compare the utility of AirtraqTM double lumen , McGRATHTM MAC video laryngoscope and the Pentax-AWS AirwayscopeTM for double-lumen endotracheal tube intubation in patients undergoing elective surgery by one experienced anesthesiologist.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intubation time
Key secondary outcomes
laryngoscopic view
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Airtraq double lumen(+)
McGRATHTM MAC video laryngoscope (-)
Pentax-AWS Airwayscope (-)
Interventions/Control_2
Airtraq double lumen(-)
McGRATHTM MAC video laryngoscope (+)
Pentax-AWS Airwayscope (-)
Interventions/Control_3
Airtraq double lumen(-)
McGRATHTM MAC video laryngoscope (-)
Pentax-AWS Airwayscope (+)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
American Society of Anesthesiologists physical status 1 to 3
Key exclusion criteria
American Society of Anesthesiologists physical status 4
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Ritsuko |
| Middle name | |
| Last name | Masuda |
Organization
Hachioji-hospital, Tokai University School of Medicine, Hachioji
Division name
Department of Anesthesiology
Zip code
1920032
Address
1838 Ishikawamachi, Hachioji, Tokyo
TEL
042-639-1111
rinet-m@ga2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Ajimi |
Organization
Hachioji-hospital, Tokai University School of Medicine, Hachioji
Division name
Department of Anesthesiology
Zip code
1920032
Address
1838 Ishikawamachi, Hachioji, Tokyo
TEL
042-639-1111
Homepage URL
ajimi@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Hachioji-hospital, Tokai University School of Medicine, Hachioji
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Hachioji-hospital, Tokai University School of Medicine, Hachioji
Department of Anesthesiology
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
Clinical Research Administration Office ,Tokai UniversityHospital
Address
143 Shimokasuya, Isehara, Kanagawa
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.jp
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
東海大学医学部付属八王子病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 13 | 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
| 2017 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 12 | Day |
Last modified on
| 2021 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036721
