UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018236
Receipt number R000021111
Scientific Title An influence of tracheal cuff pressure under hypothermic cardioipulmonary bypass; Comparative study between Taper type tube and High pressure low volume cuff tube
Date of disclosure of the study information 2015/07/07
Last modified on 2015/08/05 10:35:50

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Basic information

Public title

An influence of tracheal cuff pressure under hypothermic cardioipulmonary bypass; Comparative study between Taper type tube and High pressure low volume cuff tube

Acronym

An influence of tracheal cuff pressure under hypothermic cardioipulmonary bypass

Scientific Title

An influence of tracheal cuff pressure under hypothermic cardioipulmonary bypass; Comparative study between Taper type tube and High pressure low volume cuff tube

Scientific Title:Acronym

An influence of tracheal cuff pressure under hypothermic cardioipulmonary bypass

Region

Japan


Condition

Condition

Cardiac disease which needs cardiac surgery under hypothrmic cardiopulmonary bypass

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate cuff pressure changes of tracheal tube by using different tracheal tubes under hypothemic cardiopulmonary bypass

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

cuff pressure changes of tracheal tube

Key secondary outcomes

postoperative sore throat and hoarseness


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Taper tracheal tube

Interventions/Control_2

HVLP tracheal 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

cardiac surgery underhypothermic cardiopulmonary bypass

Key exclusion criteria

airway disease

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Minami Toshiaki

Organization

Osaka Medical College

Division name

Anesthesiology

Zip code


Address

2-7 Daigaku-machi Takatsuki Osaka

TEL

072-683-1221

Email

ane022@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sawai Toshiyuki

Organization

Osaka Medical College

Division name

Anesthesiology

Zip code


Address

2-7 Daigaku-machi Takatsuki Osaka

TEL

072-683-1221

Homepage URL


Email

ane026@poh.osaka-med.ac.jp


Sponsor or person

Institute

Department of Anesthesiology Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical College

Organization

Division

Category of Funding Organization

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 07 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


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

Enrolling by invitation

Date of protocol fixation

2015 Year 07 Month 06 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 06 Day

Last follow-up date

2018 Year 07 Month 06 Day

Date of closure to data entry

2018 Year 07 Month 06 Day

Date trial data considered complete

2018 Year 07 Month 06 Day

Date analysis concluded

2018 Year 07 Month 06 Day


Other

Other related information



Management information

Registered date

2015 Year 07 Month 07 Day

Last modified on

2015 Year 08 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021111


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name