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 UMIN000023691
Receipt No. R000027279
Scientific Title Measurement of cerebral oxygen saturation during one-lung ventilation with method of spatial resolved spectroscopy
Date of disclosure of the study information 2016/08/19
Last modified on 2019/08/16

* 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 Measurement of cerebral oxygen saturation during one-lung ventilation with method of spatial resolved spectroscopy
Acronym Measurement of cerebral oxygen saturation during one-lung ventilation with method of spatial resolved spectroscopy
Scientific Title Measurement of cerebral oxygen saturation during one-lung ventilation with method of spatial resolved spectroscopy
Scientific Title:Acronym Measurement of cerebral oxygen saturation during one-lung ventilation with method of spatial resolved spectroscopy
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Anesthesiology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 There are a few reports about cerebral regional oxygen saturation (CRSO2) during one-lung ventilation (OLV) in lung resection surgery. One study reported CRSO2 decreased by more than 15% during OLV. (Br J Anaeth. 2008; 101: 870) Another study investigated CRSO2 during OLV and cardiac index (CI) using FloTracTM system (Edwards Life Science)(Can J Anesth 2013; 60: 660). CRSO2 decreased, however, there is no significant relationship between them. In these previous reports, CRSO2 was measured by near-infrared spectroscopy with modified Beer-Lambert (MBL) method. In this study, we investigated changes of CRSO2 during OLV by using NIRO-200NX (Hamamatsu Photonics, Japan) which has a principle of Spatial Resolved Spectroscopy (SRS) method. It was reported that CRSO2 measured by SRS was not affected by individual factors such as hemoglobin concentration and skull thickness compared to MBL method (Anesthesiology 2007; 106: 458)
Basic objectives2 Others
Basic objectives -Others investigation of the factors which correlate with changes of cerebral oxygen saturation
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Measurement of cerebral oxygen saturation during one-lung ventilation with method of spatial resolved spectroscopy
Key secondary outcomes Investigation of the factors which correlate with changes of cerebral oxygen saturation

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 adult patients undergoing video-assisted thoracoscopic lung resection surgery which need OLV technique more than an hour
Key exclusion criteria the patients with more than ASA classification 3, obstructive ventilator disturbance, hemorrhage diathesis, cerebrovascular disturbance, or mental disorder
Target sample size 17

Research contact person
Name of lead principal investigator
1st name Nobuhiro
Middle name
Last name Tanaka
Organization Hokkaido University Graduate School of Medicine
Division name Department of Anesthesiology and Critical Care Medicine
Zip code 0608648
Address N14,W5,Kita-ku,Sapporo City,Hokkaido
TEL 0117067861
Email bolero0302@huhp.hokudai.ac.jp

Public contact
Name of contact person
1st name Nobuhiro
Middle name
Last name Tanaka
Organization Hokkaido University Graduate School of Medicine
Division name Department of Anesthesiology and Critical Care Medicine
Zip code 0608648
Address N14,W5,Kita-ku,Sapporo City,Hokkaido
TEL 0117067861
Homepage URL
Email bolero0302@huhp.hokudai.ac.jp

Sponsor
Institute Department of Anesthesiology and Critical Care Medicine,Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
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 Hokkaido University Hospital Division of Clinical Research Administration
Address N14W5,Kita-ku,Sapporo,Japan
Tel 011-706-7636
Email crjimu@huhp.hokudai.ac.jp

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 北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 19 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 12 Month 24 Day
Date of IRB
2014 Year 12 Month 24 Day
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2016 Year 12 Month 31 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information We designed prospective observation study for adult patients undergoing video-assisted thoracoscopic lung resection surgery which need OLV technique more than an hour. We excluded the patients with more than ASA classification 3, obstructive ventilator disturbance, hemorrhage diathesis, cerebrovascular disturbance, or mental disorder. Anesthetic method was combined general anesthesia with sevoflurane and epidural anesthesia. We monitored the patients with direct arterial sphygmomanometery using FloTracTM system and NIRO-200NX in addition to standard monitoring.

Management information
Registered date
2016 Year 08 Month 19 Day
Last modified on
2019 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027279

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.