UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024740 |
|---|---|
| Receipt number | R000027957 |
| Scientific Title | Comparison of double-lumen tracheal tube between Airwayscope and McGRATH MAC; randomized controlled trial |
| Date of disclosure of the study information | 2016/11/07 |
| Last modified on | 2017/01/20 18:01:49 |
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Basic information
Public title
Comparison of double-lumen tracheal tube between Airwayscope and McGRATH MAC; randomized controlled trial
Acronym
Comparison of double-lumen tracheal tube between Airwayscope and McGRATH MAC
Scientific Title
Comparison of double-lumen tracheal tube between Airwayscope and McGRATH MAC; randomized controlled trial
Scientific Title:Acronym
Comparison of double-lumen tracheal tube between Airwayscope and McGRATH MAC
Region
| Japan |
Condition
Condition
Patients who undergo respiratory surgery.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy of McGRATH MAC and Airwayscope for double-lumen tube intubation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intubation efficacy(intubation time, number of tracheal intubation, number of laryngoscopy.)
Key secondary outcomes
Incidence of pharyngeal pain and hoarseness. Subjective difficulty of laryngoscopy and tracheal tube passage through the glottis.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Double lumen tube intubation using Airwayscope.
Interventions/Control_2
Double lumen tube intubation using McGRATH
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who are planned to undergo respiratory surgery under general anesthesia.
Key exclusion criteria
Patients for emergency surgery.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Minami |
Organization
Osaka Medical College
Division name
Dept of Anestheisology
Zip code
Address
2-7 Daigaku-machi, Takatsuk city
TEL
0726-84-6361
ane022@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@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
| 2016 | Year | 11 | Month | 07 | 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
Intubation time was signifciantly longer in the AWS group compared to McGRATH group.
While number of laryngosopy did not significantly differ, number of intubation trial was significnatly higher in the AWS trial than in the McGRATH trial.
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
| 2016 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 18 | Day |
Date of closure to data entry
| 2017 | Year | 01 | Month | 20 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The incidence of pharyngeal pain or hoarseness did not significantly differ between the groups.
While the VAS about laryngoscopy did not significanly differ between the groups, the VAS about tube passage through the glottis was higher in the AWS group than in the McGRATH group.
Management information
Registered date
| 2016 | Year | 11 | Month | 07 | Day |
Last modified on
| 2017 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027957
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
