UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008855
Receipt No. R000010345
Scientific Title Evaluation of pulse cooximetry in patients with large skin-surface temperature gradients
Date of disclosure of the study information 2012/09/08
Last modified on 2013/09/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of pulse cooximetry in patients with large skin-surface temperature gradients
Acronym Evaluation of pulse cooximetry in patients with large skin-surface temperature gradients
Scientific Title Evaluation of pulse cooximetry in patients with large skin-surface temperature gradients
Scientific Title:Acronym Evaluation of pulse cooximetry in patients with large skin-surface temperature gradients
Region
Japan

Condition
Condition Surgical patients
Classification by specialty
Anesthesiology Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the performance of intra-operative SpHb in anesthetized patients whose skin-surface temperature gradients is likely to be large.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The differences with the intra-operative SpHb and arterial Hb in anesthetized patients whose skin-surface temperature gradients is likely to be large
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 Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 The estimating the accuracy of pulse hemoglobin (SpHb) measurement using Radical-7®
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. The necessity of invasive arterial catherter determined by independent anesthesiologist
4. expected large volume blood loss
Key exclusion criteria 1. patiets with periferal arterial disease
2. patients with nail problem
3. abnormal erythrocyte
4.Low periferal perfusion "Low signal IQ"
5.Inadequate patients determied by anesthesiologist
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 Anesthsia and CCM
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5714
Email shoka@kuaccm.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Yamaura
Organization Kyushu University Hospital
Division name Department of Anesthesia and CCM
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5714
Homepage URL
Email keny@kuaccm.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

Funding Source
Organization Kyushu University
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
2012 Year 09 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially 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
2011 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 27 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 09 Month 05 Day
Last modified on
2013 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010345

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.