UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006867
Receipt number R000004796
Scientific Title The study of ventilatory response to hypercapnia by the rebreathing methods with the new insturuments and protocol
Date of disclosure of the study information 2011/12/10
Last modified on 2014/07/09 15:30:58

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Basic information

Public title

The study of ventilatory response to hypercapnia by the rebreathing methods with the new insturuments and protocol

Acronym

The study of ventilatory response to hypercapnia by the rebreathing methods with new protocol

Scientific Title

The study of ventilatory response to hypercapnia by the rebreathing methods with the new insturuments and protocol

Scientific Title:Acronym

The study of ventilatory response to hypercapnia by the rebreathing methods with new protocol

Region

Japan


Condition

Condition

no disease

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the clinical validity about the method of measurement that use a new rebreathing instrument,and to investigate the ventilatory response to carbon dioxide,comparing the mixture gas of 7% CO2 and 93% oxygen with 100% oxygen.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Minute ventilation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment Other

Interventions/Control_1

To make rebreathe initial mixture gas, 7% carbon dioxide and 93% oxigen,or 100% oxigen.

Interventions/Control_2


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

Key inclusion criteria

healthy men

Key exclusion criteria

patients with pulmonary disease,neuromuscular disease,heart disease,cerebrovascular diseiase

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroka Hashimoto

Organization

School of Medicine,Keio University

Division name

Department of Anesthesiology

Zip code


Address

35 Shinanomachi,Shinjuku-ku,Tokyo

TEL

08067424594

Email

hokulani.h@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Hiroka Hashimoto

Organization

School of Medicine,Keio University

Division name

Department of Anesthesiology

Zip code


Address

35 Shinanomachi,Shinjuku-ku,Tokyo

TEL

0333531211

Homepage URL


Email

hokulani.h@gmail.com


Sponsor or person

Institute

School of Medicine,Keio University

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology,School of Medicine,Keio University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Jpapn


Other related organizations

Co-sponsor

Nihon Kohden Corporation

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

慶應義塾大学病院(東京都)、日本光電株式会社(東京都)


Other administrative information

Date of disclosure of the study information

2011 Year 12 Month 10 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

Completed

Date of protocol fixation

2010 Year 05 Month 31 Day

Date of IRB


Anticipated trial start date

2010 Year 08 Month 01 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

2011 Year 12 Month 09 Day

Last modified on

2014 Year 07 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004796


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name