UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004098
Receipt number R000004733
Scientific Title Cardiovascular response and tolerance in colonoscopy: a comparison between air and carbon dioxide gas supply
Date of disclosure of the study information 2010/08/25
Last modified on 2016/10/24 19:23:34

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Basic information

Public title

Cardiovascular response and tolerance in colonoscopy: a comparison between air and carbon dioxide gas supply

Acronym

A comparison between air and carbon dioxide gas supply in colonoscopy

Scientific Title

Cardiovascular response and tolerance in colonoscopy: a comparison between air and carbon dioxide gas supply

Scientific Title:Acronym

A comparison between air and carbon dioxide gas supply in colonoscopy

Region

Japan


Condition

Condition

colon polyp

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

comparison of cardiovascular responses and tolerance between air and carbon dioxide gas supply in colonoscopy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

HF (high-frequency component) by complex demodulation analysis of ECG

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

air supply

Interventions/Control_2

carbon dioxyde gas supply

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

hospitalized patient who is going to recieve colon endoscopic polypectomy

Key exclusion criteria

1.patient who needs sedation
2.patient with chronic atrial flutter or frequent extrasystole
3. patient with diabetes under treatment
4. patient who takes antiarrhythmic agent or anticholinergic agent or beta-blocker or drugs for the autonomic nervous system
5. patient with chronic obstructive pulmonary disease, COPD, chronic obstructive lung disease, COLD

Target sample size

170


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiromi Kataoka

Organization

Nagoya City University Gradute School of Medical Sciences

Division name

Division of Endoscopy, Dept of Gastroenterology and Metabolism

Zip code


Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Nagoya City University Gradute School of Medical Sciences

Division name

Division of Endoscopy, Dept of Gastroenterology and Metabolism

Zip code


Address


TEL

052-851-5511

Homepage URL


Email



Sponsor or person

Institute

Dept of Gastroenterology and Metabolism, Nagoya City University Gradute School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

Dept of Gastroenterology and Metabolism, Nagoya City University Gradute School of Medical Sciences

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



Other administrative information

Date of disclosure of the study information

2010 Year 08 Month 25 Day


Related information

URL releasing protocol


Publication of results

Published


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 08 Month 06 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date

2013 Year 04 Month 12 Day

Date of closure to data entry

2013 Year 04 Month 12 Day

Date trial data considered complete

2013 Year 12 Month 31 Day

Date analysis concluded

2013 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2010 Year 08 Month 25 Day

Last modified on

2016 Year 10 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004733


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name