UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017290
Receipt number R000020060
Scientific Title Comparison of the value of near infra-red oxygenation monitor and regional saturation under general anesthesia
Date of disclosure of the study information 2015/04/28
Last modified on 2018/06/24 22:55:59

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Basic information

Public title

Comparison of the value of near infra-red oxygenation monitor and regional saturation under general anesthesia

Acronym

Comparison of the value of near infra-red oxygenation monitor and regional saturation under general anesthesia

Scientific Title

Comparison of the value of near infra-red oxygenation monitor and regional saturation under general anesthesia

Scientific Title:Acronym

Comparison of the value of near infra-red oxygenation monitor and regional saturation under general anesthesia

Region

Japan


Condition

Condition

Patients whom were scheduled to operation

Classification by specialty

Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Breast surgery Obstetrics and Gynecology Dermatology
Oto-rhino-laryngology Orthopedics Urology
Oral surgery Cardiovascular surgery Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

the purpose is to comparison the value of NIRO (Near Infra-Red Oxygenation monitor) and rSO2 (resional saturation) by INVOS under general anesthesia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the change of O2Hb and rSO2, analysis of arterial blood sample, correlation between SvO2 and O2Hb or rSO2

Key secondary outcomes

the change of rSO2, analysis of arterial blood sample,correlation between SvO2 and O2Hb or rSO2, postoperative complication contained brain function


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

NIRO was used during operation

Interventions/Control_2

INVOS was used during operation

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

15 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

Patients aged 15 to 90, whom are necessary to use the monitoring of regional saturation

Key exclusion criteria

Patients refused the participation of the study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsutaka Edanaga

Organization

Sapporo Medical University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-611-2111

Email

edanaka@sapmed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Takeda

Organization

Sapporo Medical University School of Medicine

Division name

Hospital Division

Zip code


Address

S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-611-2111

Homepage URL


Email

hiroshi.takeda@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Sapporo Medical University School of Medicine

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 04 Month 28 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

2014 Year 06 Month 18 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 31 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

2015 Year 04 Month 27 Day

Last modified on

2018 Year 06 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020060


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name