UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008721 |
|---|---|
| Receipt number | R000009578 |
| Scientific Title | Changes in functional residual capacity in lapaloscopic abdominal surgery |
| Date of disclosure of the study information | 2012/08/25 |
| Last modified on | 2017/01/02 16:35:44 |
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Basic information
Public title
Changes in functional residual capacity in lapaloscopic abdominal surgery
Acronym
Changes in functional residual capacity during surgery
Scientific Title
Changes in functional residual capacity in lapaloscopic abdominal surgery
Scientific Title:Acronym
Changes in functional residual capacity during surgery
Region
| Japan |
Condition
Condition
Patient who had been scheduled abdominal laparoscopic surgery.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the functional residual capacity before start of surgery and after the end of surgery, to examine the transition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in functional residual capacity during surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients were ventilated with PEEP 0cmH2O during surgery.
Interventions/Control_2
Patients were ventilated with PEEP 5cmH2O during surgery.
Interventions/Control_3
Patients were ventilated with PEEP 10cmH2O during surgery.
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
patients of ASA physical status 1-2,those underwent respiratory function tests before surgery the day before surgery
Key exclusion criteria
Something other than 12mmHg pressure pneumoperitoneum
was moved to open surgery
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Terumi Marui |
Organization
Showa University
Division name
Department of Anesthesiology
Zip code
Address
1-5-8 hatanodai,Shinagawa-ku,Tokyo,Japan
TEL
03-3784-8575
marumaru@wj9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Terumi Marui |
Organization
Showa university
Division name
Department of Anesthesiology
Zip code
Address
1-5-8 hatanodai,Shinagawa-ku,Tokyo,Japan
TEL
03-3784-8575
Homepage URL
marumaru@wj9.so-net.ne.jp
Sponsor or person
Institute
Department of Anesthesiology,Showa University
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
Address
Tel
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
昭和大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 25 | 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
Main results already published
Date of protocol fixation
| 2011 | Year | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 19 | Day |
Last modified on
| 2017 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009578
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
