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Recruitment status Completed
Unique ID issued by UMIN UMIN000016119
Receipt No. R000018287
Scientific Title Cuff pressure change analysis by head and bofy position change
Date of disclosure of the study information 2015/01/05
Last modified on 2015/04/16

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Basic information
Public title Cuff pressure change analysis by head and bofy position change
Acronym Cuff pressure change analysis
Scientific Title Cuff pressure change analysis by head and bofy position change
Scientific Title:Acronym Cuff pressure change analysis
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the cuff pressue change by head and body position change. Comapring the HVLP and Taper cuff too.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cuff pressure change by head and neck positions
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Cross-over
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 Cuff pressure analysis by head and body position change with HVLP tube
Interventions/Control_2 Cuff pressure analysis by head and body position change with Taper tube
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Patients who undergo general anesthesia with tracheal intubation
Key exclusion criteria Cervical Disease Patients
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minami Toshiaki
Organization Osaka Meidcal college
Division name Depat of Anestheisology
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 Komasawa Nobuyasu
Organization Osaka Medical College
Division name Department of 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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
2015 Year 01 Month 05 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
cuff inflation was significantly decreased in Taper than in HVLP. 
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
2015 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 05 Day
Last follow-up date
2015 Year 04 Month 20 Day
Date of closure to data entry
2015 Year 04 Month 21 Day
Date trial data considered complete
2015 Year 04 Month 30 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 01 Month 05 Day
Last modified on
2015 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018287


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