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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020451
Receipt No. R000022673
Scientific Title Comparison of AWS and McGRATH MAC mediated tracehal intubation under cricoid pressure
Date of disclosure of the study information 2016/01/07
Last modified on 2016/03/17

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Basic information
Public title Comparison of AWS and McGRATH MAC mediated tracehal intubation under cricoid pressure
Acronym Tracehal intubation under cricoid pressure with AWS or McGRATH
Scientific Title Comparison of AWS and McGRATH MAC mediated tracehal intubation under cricoid pressure
Scientific Title:Acronym Tracehal intubation under cricoid pressure with AWS or McGRATH
Region
Japan

Condition
Condition Patients who undergo elective general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the tracheal intubation efficacy under 30N cricoid pressure between AWS and McGRATH MAC
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intubation time
Key secondary outcomes Number of Introck insertion, number of tracheal tube advancement. Postoperatice patient hoarseness and pharyngeal pain. Visual analogue scale utilizing VAS about 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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Tracehal intubation under 30N cricoid pressure is performed with McGRATH MAC.
Interventions/Control_2 Tracehal intubation under 30N cricoid pressure is performed with AWS.
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 Patient with elective surgery
Key exclusion criteria Intubation difficulty
BMI<35 morbid obesity
Emergency opeation
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Minami
Organization Osaka Medical College
Division name Anesgthesiology
Zip code
Address 2-7 Daigaku-machi, Takatsuk city
TEL 0726-84-6361
Email ane022@poh.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
Email ane078@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

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
Email

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 01 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 significanlty longer in the AWS trial than in the McGRATH trial under cricoid pressure.

Tracheal intubation attempt number was also significantly higher in the AWS group than in the McGRATH group under cricoid pressure.
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 01 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 06 Day
Last follow-up date
2016 Year 03 Month 16 Day
Date of closure to data entry
2016 Year 03 Month 18 Day
Date trial data considered complete
2016 Year 03 Month 19 Day
Date analysis concluded
2016 Year 03 Month 20 Day

Other
Other related information Number of laryngoscopy, Cormack grade, POGO score did not significantly differ.

Subjective difficulty of laryngoscopy did not differ significantly, while that of tracheal tube passage was significantly higher in the AWS group than in the McGRATH group.

Management information
Registered date
2016 Year 01 Month 06 Day
Last modified on
2016 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022673

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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