UMIN-CTR Clinical Trial

Basic information
Public title	Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery in Trendelenburg Head-down Position
Acronym	Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery in Trendelenburg Head-down Position
Scientific Title	Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery in Trendelenburg Head-down Position
Scientific Title:Acronym	Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery in Trendelenburg Head-down Position
Region	Japan

Condition
Condition	Perioperative Complication
Classification by specialty	Anesthesiology Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to verify whether the lung recruitment during laparoscopic surgery in Trendelenburg head-down position prevents hypoxemia due to lung collapse.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of hypoxia and Time to onset of hypoxia
Key secondary outcomes	Rate of decrease in SpO2 Ventilator setting at the end of surgery Compliance rate of lung recruitment Safety endpoint: Circulatory agonist use Circulatory agonist use, total fluid infusion, the incidence of complications

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	lung recruitment. Automatic lung recruitment using the anesthetic machines (with PEEP 15 cmH2O for 30 seconds) will be performed every 30 minutes during laparoscopy.
Interventions/Control_2	Standard ventilatory management. After tracheal intubation, standard ventilatory management (metered ventilation) should be performed with the following initial settings, and rescue should be performed when hypoxemia occurs,if necessary. [initial setting] PEEP 4cmH2O, FIO2 0.3 Ventilation rate: 6-8 ml/kg predicted body weight(PBW).
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing low head laparoscopic surgery who are expected to be laparoscopic for more than 2 hours
Key exclusion criteria	Lateral or supine position BMI > 35 One-second rate <70%, %VC <80%, obstructive, restrictive, with bra Cardiovascular disease (NYHA III or higher) Intracranial hypertensive disease Emergency surgery Pregnancy Patients judged unsuitable by the anesthesiologist in charge
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Fujino
Organization	Osaka University
Division name	Department of Anesthesiology and Intensive Care Medicine
Zip code	565-0871
Address	2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL	+81-6-6879-5820
Email	fujino@anes.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Fujino
Organization	Osaka University
Division name	Department of Anesthesiology and Intensive Care Medicine
Zip code	565-0871
Address	2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL	+81-6-6879-5820
Homepage URL
Email	fujino@anes.med.osaka-u.ac.jp

Sponsor
Institute	Department of Anesthesiology and Intensive Care Medicine, Osaka University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Anesthesiology, Toho University Ohashi Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Review Board, Osaka University Hospital
Address	2-2 Yamadaoka, Suita city, Osaka, 565-0871 JAPAN
Tel	+81662108296
Email	rinri@hp-crc.med.osaka-u.ac.jp

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	大阪大学医学部附属病院（大阪府）、東邦大学医療センター大橋病院（東京都）

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 04 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	Preinitiation
Date of protocol fixation	2021 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2023 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 04 Day
Last modified on	2021 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049359