UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023691 |
|---|---|
| Receipt number | 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 | 2022/04/28 00:11:41 |
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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
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
bolero0302@huhp.hokudai.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Critical Care Medicine,Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
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
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
https://doi.org/10.1016/j.jclinane.2019.06.035
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.jclinane.2019.06.035
Number of participants that the trial has enrolled
17
Results
TOI values significantly decreased during OLV; however, the degree of desaturation was only approximately 6% from baseline.
Intracranial cerebral desaturation during OLV may not be as severe as previously reported. The changes in CRSO2 were related to the changes in SaO2 and pCO2. Therefore, suppressing the decrease in SaO2 as much as possible while simultaneously maintaining PaCO2 at slightly higher levels may be important in surgery using OLV.
Results date posted
| 2022 | Year | 04 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients scheduled for lung resection surgery under thoracoscopy requiring one-lung ventilation (OLV) for>1 h under epidural/general inhalation anesthesia were enrolled.
Participant flow
Entries were made when the criteria were met and incorporated when consent was actually obtained.
Adverse events
nothing particular
Outcome measures
Changes in TOI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2022 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027279
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