Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000861257
Ethics application status
Approved
Date submitted
30/09/2009
Date registered
6/10/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Intraoperative Safety and Postoperative Lung Complications between two ventilation methods during lung resection surgery
Scientific title
Comparison of Intraoperative Safety and Postoperative Lung Complications between Conventional and Protective One Lung Ventilation Strategies in Lung Resection Surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lung cancer 251944 0
Condition category
Condition code
Anaesthesiology 252129 252129 0 0
Other anaesthesiology
Surgery 252153 252153 0 0
Surgical techniques
Cancer 252154 252154 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The protective ventilation strategy consists of fraction of inspired oxygen (FiO2) 0.5, tidal volume 6 ml//kg, end expiratory pressure 5 cmH2O, and pressure controlled ventilation./protective ventilation strategy applied during one lung ventilation (approximately 60 minutes)
Intervention code [1] 241363 0
Prevention
Intervention code [2] 241379 0
Treatment: Surgery
Comparator / control treatment
The conventional strategy consists of FiO2 1.0, tidal volume 10 ml/kg, zero end expiratory pressure, and volume controlled ventilation/conventional strategy applied during one lung ventilation (approximately 60 minutes)
Control group
Active

Outcomes
Primary outcome [1] 253008 0
Lung complications within postoperative one week: arterial oxygen partial pressure (PaO2)/FiO2 < 300 mmHg, and/or lung infiltration and atelectasis. Lung lesion is assessed by chest x-ray
Timepoint [1] 253008 0
Postoperative one week
Secondary outcome [1] 257784 0
Intraoperative safety: oxygen saturation by pulse oxymeter, arterial carbon dioxide partial pressure, and airway pressure
Timepoint [1] 257784 0
During operation

Eligibility
Key inclusion criteria
1. Lung resction surgery: lobectomy, bilobectomy.
2. American society of anesthesiology physical status 1 or 2
3. Patients acceptance for the study
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. patient’s refusal
2. cerebral, renal or liver diseases

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolling: All patienst who meet the inclusion criteria during the study period
Allocating: Sealed envelope assignment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 2209 0
Korea, Republic Of
State/province [1] 2209 0

Funding & Sponsors
Funding source category [1] 243822 0
Self funded/Unfunded
Name [1] 243822 0
Country [1] 243822 0
Primary sponsor type
Individual
Name
Hyun Joo Ahn
Address
Department of Anesthesiology and Pain Medicine, Samsung Medical Center, 50, Ilwon-Dong, Kangnam-Gu, Seoul, Korea, 135-710
Country
Korea, Republic Of
Secondary sponsor category [1] 237172 0
None
Name [1] 237172 0
Address [1] 237172 0
Country [1] 237172 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243951 0
Institutional review board of Samsung medical center
Ethics committee address [1] 243951 0
Samsung Medical Center,
50, Ilwon-Dong, Kangnam-Gu, Seoul, Korea, 135-710
Ethics committee country [1] 243951 0
Korea, Republic Of
Date submitted for ethics approval [1] 243951 0
23/01/2009
Approval date [1] 243951 0
02/02/2009
Ethics approval number [1] 243951 0
2009-01-043

Summary
Brief summary
Purpose: Comparison of postoperative lung complications between two ventilation methods in lung resection surgery.
Hypothesis: ventilation with low tidal volume and oxygen partial pressure, application of positive endexpiratory pressure, and pressrue controlled ventilation will reduce postoperative lung complications compared to conventional ventilation methods
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30346 0
Address 30346 0
Country 30346 0
Phone 30346 0
Fax 30346 0
Email 30346 0
Contact person for public queries
Name 13593 0
Hyun Joo Ahn
Address 13593 0
Department of Anesthesiology and Pain Medicine, Samsung Medical
Center, 50, Ilwon-Dong, Kangnam-Gu, Seoul, Korea, 135-710
Country 13593 0
Korea, Republic Of
Phone 13593 0
82-2-3410-0784
Fax 13593 0
Email 13593 0
hyunjooahn@skku.edu
Contact person for scientific queries
Name 4521 0
Hyun Joo Ahn
Address 4521 0
Department of Anesthesiology and Pain Medicine, Samsung Medical
Center, 50, Ilwon-Dong, Kangnam-Gu, Seoul, Korea, 135-710
Country 4521 0
Korea, Republic Of
Phone 4521 0
82-2-3410-0784
Fax 4521 0
Email 4521 0
hyunjooahn@skku.edu

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
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Documents added automatically
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