UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An examination whether intermittent reinflation during one lung ventilation in lung resection would result in a time-dependent alteration of extravascular lung water
Title of the study (Brief title)	Management of the nonventilated lung during one lung ventilation
Region	Japan

Condition
Condition	elective video-assisted thoracic surgery for lung tumor requiring one lung ventilation
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Intermittent reinflation as repeated cycle of collapse and re-expansion of operated lung is a suggested maneuver for the prevention of hypoxemia during one lung ventilation but may impose mechanical stress for operated lung. We hypothesized that intermittent reinflation may increase extravascular lung water leading to lung injury. To test the hypothesis, we will measure extravascular lung water with or without intermittent reinflation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome is set to the change of extravascular lung water with PiCCO (Pulsion Medical Systems, Munich, Germany) determined with the single indicator transpulmonary thermodilution technique at T1; baseline time after induction of anesthesia, T2; the end of the surgical procedure and before extubation, T3; just after the admission to the ICU, and T4; 12 hour after the admission to the ICU, respectively.
Key secondary outcomes	Secondary outcome includes postoperative complications within 14 days and duration of postoperative hospitalization.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
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	Patients are randomly assigned to either group C or group IR. Group C that is control group consists of patients whose nondependent lung is kept collapsed during OLV.
Interventions/Control_2	Group IR that is intervention group includes patients with intermittent reinflation that consists of quadruple of 10-second manual inflation and 5-second open within a minute at intervals of 20 minutes during OLV.
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) ASA physical status I-II 2) elective video-assisted thoracic surgery for lung tumor requiring one lung ventilation lasting more than 120 minutes
Key exclusion criteria	1) decompensated cardiac disease (> class II in New York Heart Association) 2) chronic pulmonary disease (vital capacity < 50% of predicted values and/or forced expiratory volume in 1 second < 50% of forced vital capacity) 3) chronic renal failure (serum creatinine > 1.5 mg/dl) 4) altered liver function (> class B in Child-Pugh) 5) preoperative treatment with immune modulator (cytostatic drugs, corticosteroids, nonsteroidal antiinflammatory drugs, vaccination, and blood products) within a month before surgery 6) pre-existing coagulation disorders 7) symptoms of an acute inflammatory process (clinically defined or abnormal data for C-reactive protein, leukocyte count, or body temperature) 8) Arteriosclerosis obliterans and/or iliac artery stenosis and/or aneurysms with or without bypass surgeries, which would be associated with an increased risk of complications following the femoral arterial cannulation for PiCCO
Target sample size	36

Research contact person
Name of lead principal investigator	Masakazu YASUUJI
Organization	Hiroshima University Hospital
Division name	Department of Anesthesiology and Critical Care
Address	1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL	082-257-5267
Email	yasuuji@hiroshima-u.ac.jp

Public contact
Name of contact person	Masakazu YASUUJI
Organization	Hiroshima University Hospital
Division name	Department of Anesthesiology and Critical Care
Address	1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL	082-257-5267
Homepage URL
Email	yasuuji@hiroshima-u.ac.jp

Sponsor
Institute	Department of Anesthesiology and Critical Care, Hiroshima University Hospital
Institute
Department

Funding Source
Organization	the Grant-in-Aid for Young Scientists (B)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	広島大学病院

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2003 Year 12 Month 01 Day
Anticipated trial start date	2003 Year 12 Month 02 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	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/24793701
Results
Other related information

Management information
Registered date	2012 Year 08 Month 23 Day
Last modified on	2017 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010289