UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010745
Receipt number R000012553
Scientific Title Reliability of New Non-invasive hemoglobin monitoring with calibration function
Date of disclosure of the study information 2013/05/16
Last modified on 2018/05/21 18:09:44

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Basic information

Public title

Reliability of New Non-invasive hemoglobin monitoring with calibration function

Acronym

Reliability of New Non-invasive hemoglobin monitoring

Scientific Title

Reliability of New Non-invasive hemoglobin monitoring with calibration function

Scientific Title:Acronym

Reliability of New Non-invasive hemoglobin monitoring

Region

Japan


Condition

Condition

surgical patients

Classification by specialty

Surgery in general Hepato-biliary-pancreatic surgery Vascular surgery
Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the new noninvasive hemoglobin monitoring with calibration function in surgical patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To compare the arterial heoblobin and non-invasive hemoglobin (SpHb).

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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 and Female

Key inclusion criteria

1. adult surgical patients
2. written informed consent
3. surgical patientsin need of arterial blood draws for standard anesthetic care
4. estimated blood loss is more than 25% of blood volume

Key exclusion criteria

1. peripheral arterial disease patients
2. patihents who have problem of the fingertip
3. anemia due to abnormal hemoblobin
4. patients whom resercher think inapporpriate

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sumio Hoka

Organization

Kyushu University

Division name

Department of Anesthesia and Critical Care Medicine

Zip code


Address

Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan

TEL

092-642-5714

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kyushu University Hospital

Division name

Department of Anesthesia and CCM

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Anesthesia and CCM, Kyushu University Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesia and CCM, Kyushu University Hospital

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

2013 Year 05 Month 16 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.sciencedirect.com/science/article/pii/S0952818014001834?via%3Dihub

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

2013 Year 05 Month 14 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 14 Day

Last follow-up date

2014 Year 03 Month 31 Day

Date of closure to data entry

2014 Year 04 Month 15 Day

Date trial data considered complete

2014 Year 04 Month 15 Day

Date analysis concluded

2014 Year 04 Month 15 Day


Other

Other related information

After obtaining written informed consent, this prospective and observational study is conducted.
Besides routine monitors, direct radial arterial blood pressure and SpHb are monitored. SpHb is measured with New Radical-7; (Masimo Corporation, Irvine, CA, USA)
Time-matched SpHb is recorded only when each anesthesiologist decide to need arterial blood gas analysis for standard care. Blood samples are drawn intermittently and analyzed using Co-oximeter (Radiometer ABL 800; Radiometer, Copenhagen, Denmark).
We investigate the differences between SpHb and arterial Hb at each paired measurement.


Management information

Registered date

2013 Year 05 Month 16 Day

Last modified on

2018 Year 05 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012553


Research Plan
Registered date File name
2018/05/21 SpHbl蛟ォ逅・ァ泌藤莨・SpHb 閾ィ蠎顔?皮ゥカ險育判譖ク菫ョ豁」.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/05/21 SpHb New Data140415(患者情報無).xlsx