UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008759 |
|---|---|
| Receipt number | 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 15:17:47 |
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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
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
yasuuji@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Critical Care, Hiroshima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010289
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| Registered date | File name |
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