UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Recruitment Maneuver and Positive end-Expiratory Pressure during laparoscopic surgery on ventilation distribution
Title of the study (Brief title)	EIT monitoring during laparoscopic surgery
Region	Japan

Condition
Condition	Impairment of ventilation distribution during laparoscopic surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to investigate the effect of recruitment maneuver and ventilator settings on ventilation distribution by electrical impedance tomography during changing position and pnemoperitoneum in the patients undergoing laparoscopic surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Increase in ventilation distribution in dorsal part of the lung by recruitment maneuver and high PEEP setting during trendelenburg position and pneumoperitonium
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Set the PEEP level at 15cmH2O following recruitment maneuver until the end of surgery
Interventions/Control_2	Set the PEEP level at 5cmH2O following recruitment maneuver until the end of surgery
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Age of >20, <80 2) undergo the laparoscopic surgery for lower abdomen 3) Witten informed consent 4) Physical Status 1 or 2 classified by American Heart Association
Key exclusion criteria	1) Impaired lung function (COPD grade > 3, or FEV1s < 1000ml) 2) Chronic heart failure (Cardiac index < 1.8L/m2, NYHA > or = 3 ) 3)Unstable hemodynamics needing inotropic agents
Target sample size	40

Research contact person
Name of lead principal investigator	Atsuko Shono
Organization	Shimane University
Division name	Department of Anesthesiology, Faculty of medicine
Address	Enya 89-1, Izumo city, Shimane
TEL	0853202295
Email	atsukos@med.shimane-u.ac.jp

Public contact
Name of contact person	Atsuko Shono
Organization	Shimane University
Division name	Department of Anesthesiology, Faculty of medicine
Address	Enya 89-1, Izumo city, Shimane
TEL	0853202295
Homepage URL
Email	atsukos@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 01 Day
Date analysis concluded	2018 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 20 Day
Last modified on	2018 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025356