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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020450
Receipt No. R000022672
Scientific Title Evaluation of cricoid pressure effect on tracheal intubation with McGRATH MAC
Date of disclosure of the study information 2016/01/08
Last modified on 2016/02/22

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Basic information
Public title Evaluation of cricoid pressure effect on tracheal intubation with McGRATH MAC
Acronym Cricoid pressue effect on McGRATH intubation
Scientific Title Evaluation of cricoid pressure effect on tracheal intubation with McGRATH MAC
Scientific Title:Acronym Cricoid pressue effect on McGRATH intubation
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effect of cricoid pressure for McGRATH MAC mediated tracehal intubation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intubation time
Key secondary outcomes number of insertion, number of tracehal tube advancement, postoperative hoarseness pharyngeal pain
VAS for 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 Tracheal intubation is performed with 30N cricoid pressure with McGRATH MAC.
Interventions/Control_2 Tracheal intubation is performed without cricoid pressure with McGRATH MAC.
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 elective surgery
Key exclusion criteria emergency operation
BMI>35
difficult tracehal intubation
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 Anesthesiology
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 08 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
Cricoid pressure lengethened the intubation time with McGRATH MAC.

First intubation success rate did notdiffer significantly.
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 02 Month 23 Day
Date of closure to data entry
2016 Year 02 Month 25 Day
Date trial data considered complete
2016 Year 02 Month 25 Day
Date analysis concluded
2016 Year 03 Month 15 Day

Other
Other related information Number of laryngoscopy did not differe signficantly.

POGO score also did not significantly change.

Management information
Registered date
2016 Year 01 Month 06 Day
Last modified on
2016 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022672

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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