UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033710 |
|---|---|
| Receipt number | R000038438 |
| Scientific Title | Inhalation anesthesia gas concentration in outlet gas of oxygenator |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2020/03/18 01:27:28 |
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Basic information
Public title
Inhalation anesthesia gas concentration in outlet gas of oxygenator
Acronym
Inhalation anesthesia gas concentration in outlet gas of oxygenator
Scientific Title
Inhalation anesthesia gas concentration in outlet gas of oxygenator
Scientific Title:Acronym
Inhalation anesthesia gas concentration in outlet gas of oxygenator
Region
| Japan |
Condition
Condition
cardiovascular diseases
Classification by specialty
| Cardiovascular surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
concentration of anesthesia gas
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
concentration of anesthesia gas
Key secondary outcomes
some complications about oxygenators
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Desfrurane and one Oxygenator; terumo or Livanova or Medtoronic or Senko.
Interventions/Control_2
Sevofrulane and one Oxygenator; terumo or Livanova or Medtoronic or Senko.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All CPB cases
Key exclusion criteria
The case we cannot use anesthesia gas
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nishiwaki |
| Middle name | |
| Last name | Kimitoshi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
466-8550
Address
Nagoya
TEL
0527412111
takahiro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tamura |
| Middle name | |
| Last name | Takahiro |
Organization
Nagoya University Hospital
Division name
Department of Anesthesiology
Zip code
466-8550
Address
Nagoya
TEL
0527412111
Homepage URL
takahiro@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Nagoya University hospital
Address
Tsurumai-cho 65
Tel
+81527412111
takahiro@med.nagoya-u.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 01 | 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
| 2018 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood test of the anesthesia gas during CPB
Management information
Registered date
| 2018 | Year | 08 | Month | 10 | Day |
Last modified on
| 2020 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038438
