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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033393
Receipt No. R000037448
Scientific Title Simplified configuration of the cuff pressure using syringe
Date of disclosure of the study information 2018/07/15
Last modified on 2018/07/15

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Basic information
Public title Simplified configuration of the cuff pressure using syringe
Acronym Configuration of the cuff pressure using syringe
Scientific Title Simplified configuration of the cuff pressure using syringe
Scientific Title:Acronym Configuration of the cuff pressure using syringe
Region
Japan

Condition
Condition diseases enough to require surgery
Classification by specialty
Medicine in general Surgery in general Obsterics and gynecology
Pediatrics Orthopedics Anesthesiology
Neurosurgery Cardiovascular surgery Plastic surgery
Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether the configuration of cuff pressure of tracheal tube using 10ml syringe is possible or not.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the cuff pressure when plunger of syringe stops after inject air into cuff
Key secondary outcomes cuff volume when plunger of syringe stops
a incidence of hoarseness

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 inject 10ml air into cuff No.1
Interventions/Control_2 inject 10ml air into cuff No.2
Interventions/Control_3 inject 10ml air into cuff No.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

Not applicable
Gender Male and Female
Key inclusion criteria ASA physical status classification (ASA-PS) 1 or 2
Key exclusion criteria ASA-PS 3-6
emergency operation
special intubation(one lung ventilation, nasal intubation)
patients with a history of neck surgery
obese patients(BMI>30)
minor children
patients using TEE
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Tennnichi
Organization PHARMACEUTICAL AND HEALTH SCIENCES KANAZAWA UNIVERSITY
Division name DEPARTMENT OF ANESTHESIOLOGY FACULTY OF MEDICINE INSTITUTE OF MEDICAL
Zip code
Address 13-1, Takaramachi Kanazawa-shi, Ishikawa
TEL 0762652434
Email ttennichi@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Tennichi
Organization PHARMACEUTICAL AND HEALTH SCIENCES KANAZAWA UNIVERSITY
Division name DEPARTMENT OF ANESTHESIOLOGY FACULTY OF MEDICINE INSTITUTE OF MEDICAL
Zip code
Address 13-1, Takaramachi Kanazawa-shi, Ishikawa
TEL +81762652434
Homepage URL
Email ttennichi@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization none
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
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 金沢大学附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 15 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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 15 Day
Last modified on
2018 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037448

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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