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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017905
Receipt No. 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

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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
Email 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
Email ykotake@med.toho-u.ac.jp

Sponsor
Institute Department of Anesthesiology, Toho University Ohashi Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020744

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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