UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017905 |
|---|---|
| Receipt number | R000020744 |
| Scientific Title | Effects of preemptive treatment against intraoperative atelectasis |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2015/09/14 20:51:07 |
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Basic information
Public title
Effects of preemptive treatment against intraoperative atelectasis
Acronym
preemptive treatment against intraoperative atelectasis
Scientific Title
Effects of preemptive treatment against intraoperative atelectasis
Scientific Title:Acronym
preemptive treatment against intraoperative atelectasis
Region
| Japan |
Condition
Condition
Elective patients who undergo laparoscopic colorectal cancer surgery
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of preemptive, programmed recruitment on atelectasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Semi-quantitative assessment of atelectasis
Postoperative oxygenation
Key secondary outcomes
Postoperative pulmonary complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Preemptive application of programmed recruitment manuever
Interventions/Control_2
Usual care
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing elective, laparoscopic colorectal cancer resection under general anesthesia
Key exclusion criteria
Abnormal pulmonary function
Patients who have any pathology that makes ultrasound evaluation of atelectasis difficult
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Kotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
Address
2-17-6, Ohashi, Meguro, Tokyo
TEL
03-3468-1251
ykotake@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Kotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
Address
2-17-6, Ohashi, Meguro, Tokyo
TEL
03-3468-1251
Homepage URL
ykotake@med.toho-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Toho University Ohashi Medical Center
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
東邦大学医療センター大橋病院（東京都）
Toho University Ohashi Medical Center (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | 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
| 2015 | Year | 06 | Month | 15 | Day |
Last modified on
| 2015 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020744
