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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008759
Receipt No. R000010289
Scientific Title An examination whether intermittent reinflation during one lung ventilation in lung resection would result in a time-dependent alteration of extravascular lung water
Date of disclosure of the study information 2012/09/03
Last modified on 2017/03/05

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Basic information
Public title An examination whether intermittent reinflation during one lung ventilation in lung resection would result in a time-dependent alteration of extravascular lung water
Acronym Management of the nonventilated lung during one lung ventilation
Scientific Title An examination whether intermittent reinflation during one lung ventilation in lung resection would result in a time-dependent alteration of extravascular lung water
Scientific Title:Acronym 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
1st name
Middle name
Last name Masakazu YASUUJI
Organization Hiroshima University Hospital
Division name Department of Anesthesiology and Critical Care
Zip code
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
1st name
Middle name
Last name Masakazu YASUUJI
Organization Hiroshima University Hospital
Division name Department of Anesthesiology and Critical Care
Zip code
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)

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 広島大学病院

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/24793701
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 Completed
Date of protocol fixation
2003 Year 12 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000010289

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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