UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001516 |
|---|---|
| Receipt number | R000001826 |
| Scientific Title | Continuos effect of general anesthesia and positive end-expiratory pressure on functional residual capacity during peri-operation. |
| Date of disclosure of the study information | 2008/11/19 |
| Last modified on | 2019/08/17 10:03:44 |
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Basic information
Public title
Continuos effect of general anesthesia and positive end-expiratory pressure on functional residual capacity during peri-operation.
Acronym
Continous effect of anesthesia and PEEP on FRC
Scientific Title
Continuos effect of general anesthesia and positive end-expiratory pressure on functional residual capacity during peri-operation.
Scientific Title:Acronym
Continous effect of anesthesia and PEEP on FRC
Region
| Japan |
Condition
Condition
general anesthetized patients
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Oto-rhino-laryngology |
| Orthopedics | Urology | Neurosurgery |
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of PEEP and PEEP timing on FRC and oxygenation during peri-operation. Continuous measuring of FRC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Study of proper PEEP level by FRC during peri-operative period and effect of PEEP on prognosis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
respirator
Interventions/Control_2
level of PEEP
Interventions/Control_3
PEEP timing
Interventions/Control_4
FRC
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
not particular
Key exclusion criteria
Chronic obstructive pulmonary disease
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Daizoh |
| Middle name | |
| Last name | Satoh |
Organization
Tohoku university postgraduate medical school
Division name
department of anesthesia and perioperative medicine
Zip code
980-8574
Address
2-1 Seiryomachi, Aoba-ku, Sendai
TEL
022-717-7321
ds0226@fsinet.or.jp
Public contact
Name of contact person
| 1st name | Daizoh |
| Middle name | |
| Last name | atoh |
Organization
Tohoku university postgraduate medical school
Division name
department of anesthesia and perioperative medicine
Zip code
980-8574
Address
2-1 Seiryomachi, Aoba-ku, Sendai
TEL
022-717-7321
Homepage URL
se803714@fsinet.or.jp
Sponsor or person
Institute
department of anesthesia and perioperative medicine
Tohoku university postgraduate medical school
Institute
Department
Personal name
Funding Source
Organization
department of anesthesia and perioperative medicine
Tohoku university postgraduate medical school
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
NONE
Name of secondary funder(s)
NONE
IRB Contact (For public release)
Organization
the Ehics committee of Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-7319
ec*rinri.hosp.tohoku.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
| 2008 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2008 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2008 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 19 | Day |
Last modified on
| 2019 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001826
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
