UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in functional residual capacity in lapaloscopic abdominal surgery
Title of the study (Brief title)	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	Terumi Marui
Organization	Showa University
Division name	Department of Anesthesiology
Address	1-5-8 hatanodai,Shinagawa-ku,Tokyo,Japan
TEL	03-3784-8575
Email	marumaru@wj9.so-net.ne.jp

Public contact
Name of contact person	Terumi Marui
Organization	Showa university
Division name	Department of Anesthesiology
Address	1-5-8 hatanodai,Shinagawa-ku,Tokyo,Japan
TEL	03-3784-8575
Homepage URL
Email	marumaru@wj9.so-net.ne.jp

Sponsor
Institute	Department of Anesthesiology,Showa University
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 08 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009578