Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000477022
Ethics application status
Approved
Date submitted
7/06/2010
Date registered
10/06/2010
Date last updated
10/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Inflammation, Oxidative Stress, and Respiratory Outcomes Between Conventional and Protective One Lung Ventilation in Patients Undergoing Lung Resection Surgery
Scientific title
Comparison of Inflammation, Oxidative Stress, and Respiratory Outcomes Between Conventional and Protective One Lung Ventilation in Patients Undergoing Lung Resection Surgery for Lung Cancer
Secondary ID [1] 251965 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lung cancer 257528 0
lung lobectomy 257529 0
Condition category
Condition code
Cancer 257688 257688 0 0
Lung - Non small cell
Anaesthesiology 257689 257689 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Protective One Lung Ventilation (tidal volume 6 ml/kg, 5cmH2O positive end-expiratory pressure, inspiratory oxygen partial pressure:FiO2 0.5) / continuously applied during lobectomy (approximately 60-90 minutes).
Intervention code [1] 256623 0
Treatment: Devices
Comparator / control treatment
Conventional One Lung Ventilation (tidal volume 10 ml/kg, 0 cmH2O positive end-expiratory pressure, FiO2 1.0 / continuously applied during lobectomy (approximately 60-90 minutes).
Control group
Active

Outcomes
Primary outcome [1] 258593 0
respiratory parameters(airway pressure, tidal volume, inspiratory oxygen partial pressure:FiO2, respiratory rate) measured by pneumotachometer
Timepoint [1] 258593 0
baseline = baseline time after anesthetic induction and before ventilation strategy application; OLV 15 and OLV 60 = 15 minutes and 60 minutes after initiation of OLV, respectively; two lung ventilation(TLV) 15 = 15 minutes after the end of OLV
Primary outcome [2] 258594 0
arterial blood gas analysis: arterial partial pressure of oxygen (PaO2), arterial partial pressure of carbondioxide (PaCO2), pH
Timepoint [2] 258594 0
baseline = baseline time after anesthetic induction and before ventilation strategy application; OLV 15 and OLV 60 = 15 minutes and 60 minutes after initiation of OLV, respectively; TLV 15 = 15 minutes after the end of OLV
Primary outcome [3] 258595 0
blood interleukin 6
Timepoint [3] 258595 0
baseline = baseline time after anesthetic induction and before ventilation strategy application; OLV 60 = 60 minutes after initiation of OLV; TLV 15 = 15 minutes after the end of OLV
Secondary outcome [1] 264486 0
blood malondialdehyde
Timepoint [1] 264486 0
baseline = baseline time after anesthetic induction and before ventilation strategy application; OLV 60 = 60 minutes after initiation of OLV; TLV 15 = 15 minutes after the end of OLV
Secondary outcome [2] 264487 0
hospital stay through data linkage to patient medical records
Timepoint [2] 264487 0
when patients' discharge
Secondary outcome [3] 264488 0
chest radiograph
Timepoint [3] 264488 0
every day for 1 week postoperatively

Eligibility
Key inclusion criteria
American Society of Anesthesiologist (ASA) physical status 1-2 and scheduled for an elective video-assisted thoracoscopic (VATS) lobectomy due to lung cancer
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patient’s refusal to take part in the study, coexisting chronic obstructive lung disease with forced expiratory volume in 1 s of less than 80% of predicted and/or forced expiratory volume in 1 s over forced vital capacity ratio of less than 0.7, chronic renal failure, altered liver function, preoperative corticosteroid treatment during one month before operation, elevated temperature or leukocyte count, or any new pulmonary infiltration on the chest radiography (CXR).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2688 0
Korea, Republic Of
State/province [1] 2688 0

Funding & Sponsors
Funding source category [1] 257111 0
Hospital
Name [1] 257111 0
Samsung Medical Center Clinical Research Development Program grant, CRS110-07-1
Country [1] 257111 0
Korea, Republic Of
Primary sponsor type
Individual
Name
Jie Ae Kim
Address
Department of anesthesiology and pain medicine. Samsung Medical Center, 50 Ilwon-dong, Kangnam-gu, Seoul 135-710, South Korea
Country
Korea, Republic Of
Secondary sponsor category [1] 256373 0
Individual
Name [1] 256373 0
Hyun Joo Ahn
Address [1] 256373 0
Department of anesthesiology and pain medicine. Samsung Medical Center, 50 Ilwon-dong, Kangnam-gu, Seoul 135-710, South Korea
Country [1] 256373 0
Korea, Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259152 0
Institutional review board
Ethics committee address [1] 259152 0
50 Ilwon-dong, Kangnam-gu, Seoul 135-710, South Korea
Ethics committee country [1] 259152 0
Korea, Republic Of
Date submitted for ethics approval [1] 259152 0
03/01/2009
Approval date [1] 259152 0
07/02/2009
Ethics approval number [1] 259152 0
2009-01-043-001

Summary
Brief summary
This study compared inflammatory and oxidative stress, and respiratory outcomes between conventional and protective OLV in patients with normal lung function undergoing video-assisted thoracoscopic (VATS) lobectomy due to lung cancer.
Fifty ASA 1-2 patients undergoing elective VATS lobectomy were randomly assigned into conventional (CV: tidal volume 10 ml/kg, FiO2 1.0, zero positive end-expiratory pressure under volume-controlled ventilation) or protective (PV: tidal volume 6 ml/kg, FiO2 0.5, positive end-expiratory pressure 5 cmH2O under pressure-controlled ventilation) OLV group. Respiratory parameters, arterial blood gases, blood malondialdehyde (MDA) and interleukin 6 (IL 6) were analyzed at baseline, 15 min and 60 min after OLV (OLV 15 and OLV 60, respectively), and 15 min after the restoration of two lung ventilation (TLV 15). Postoperative chest radiography (CXR) and respiratory outcomes were also evaluated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31269 0
Address 31269 0
Country 31269 0
Phone 31269 0
Fax 31269 0
Email 31269 0
Contact person for public queries
Name 14516 0
Jie Ae Kim
Address 14516 0
Department of anesthesiology and pain medicine. Samsung Medical Center, 50 Ilwon-dong, Kangnam-gu, Seoul 135-710, South Korea
Country 14516 0
Korea, Republic Of
Phone 14516 0
82-2-3410-0363
Fax 14516 0
Email 14516 0
[email protected]
Contact person for scientific queries
Name 5444 0
Jie Ae Kim
Address 5444 0
Department of anesthesiology and pain medicine. Samsung Medical Center, 50 Ilwon-dong, Kangnam-gu, Seoul 135-710, South Korea
Country 5444 0
Korea, Republic Of
Phone 5444 0
82-2-3410-0363
Fax 5444 0
Email 5444 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIComparison between Conventional and Protective One-Lung Ventilation for Ventilator-Assisted Thoracic Surgery2012https://doi.org/10.1177/0310057x1204000505
N.B. These documents automatically identified may not have been verified by the study sponsor.