Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000274875
Ethics application status
Not yet submitted
Date submitted
1/03/2012
Date registered
8/03/2012
Date last updated
8/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Do maneuvers to re-inflate collapsed areas of lung during surgery for lung cancer help to improve post-operative oxygen levels?
Scientific title
'Effects of alveolar recruitment during one-lung ventilation for lung cancer surgery on post-operative arterial oxygenation'
Secondary ID [1] 279845 0
Nil
Universal Trial Number (UTN)
U1111-1127-6509
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer surgery 285731 0
Condition category
Condition code
Anaesthesiology 285914 285914 0 0
Anaesthetics
Cancer 286166 286166 0 0
Lung - Non small cell
Cancer 286167 286167 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an alveolar recruitment maneuver, which involves a brief period of increased airway pressures with the aim of re-inflating collapsed lung units. The specific alveolar recruitment protocol will be performed with pressure controlled ventilation, for a duration of 60 seconds, with a respiratory rate of 12 breaths/min, inspiratory:expiratory ratio of 1:1, peak airway pressures of 30cmH2O and PEEP of 10cmH2O during the maneuver.
Recruitment will be performed at two time-points during surgery:
1) After onset of lung isolation, to the dependent lung
2) After completion of surgery, to both the dependent and operative lung in a sequential manner.
Intervention code [1] 284167 0
Treatment: Other
Comparator / control treatment
Standard treatment with a protective one-lung ventilation strategy, including low tidal volume ventilation and limiting peak and plateau airway pressures.
Control group
Active

Outcomes
Primary outcome [1] 286408 0
Post-operative arterial oxygenation as assessed by arterial blood gas machine.
Timepoint [1] 286408 0
1 hour, 4 hours, 24 horus, and 48 hours post-operatively.
Secondary outcome [1] 295791 0
Atelectasis detected on post-operative chest x-rays.
Timepoint [1] 295791 0
Development of atelectasis at any time during the post-operative period whilst an inpatient, as assessed on chest x-rays performed as part of routine care.
Secondary outcome [2] 295792 0
Post-operative acute lung injury or acute respiratory distress syndrome, as defined by the American-European consensus criteria for ALI/ARDS.
Timepoint [2] 295792 0
Any time within the post-operative period whilst an inpatient in hospital.
Secondary outcome [3] 295793 0
Post-operative respiratory failure requiring re-intubation.
Timepoint [3] 295793 0
Any time within the post-operative period whilst an inpatient in hospital.
Secondary outcome [4] 295794 0
Post-operative pneumonia, defines as: 'Pulmonary infiltrates that are new or progressing on chest x-ray, plus findings suggesting inflammation (new onset fever, purulent sputum, leucocytosis, and/or positive sputum culture).'
Timepoint [4] 295794 0
Any time within the post-operative period whilst an inpatient in hospital.
Secondary outcome [5] 296333 0
Post-operative inflammation, measured by serum cytokines
Timepoint [5] 296333 0
24 hours post-operatively

Eligibility
Key inclusion criteria
Patients undergoing elective thoracic surgery with one lung ventilation for cancer resection (wedge resection or lobectomy).
Age > 18 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are not competent to consent for themselves.
Patients under the age of 18 years.
Pregnant women.
Pre-operative haemodynamic instability.
Intra-operative blood loss >500ml.

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)
Patients will be identified through the pre-anaesthesia clinic.
Allocation concealment will be carried out via sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be via sequence generation via permuted block randomization. Patients will be randomized on the day of surgery.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 284613 0
Self funded/Unfunded
Name [1] 284613 0
Country [1] 284613 0
Australia
Primary sponsor type
Individual
Name
Dr Marissa Ferguson
Address
Peter MacCallum Hospital,
St Andrews Place,
East Melbourne,
Victoria 3002
Country
Australia
Secondary sponsor category [1] 283542 0
Individual
Name [1] 283542 0
Dr Bernhard Riedel
Address [1] 283542 0
Peter MacCallum Hospital,
St Andrews Place,
East Melbourne,
Victoria 3002
Country [1] 283542 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286606 0
Peter MacCallum Hospital
Ethics committee address [1] 286606 0
Peter MacCallum Hospital,
St Andrews Place,
East Melbourne,
Victoria 3002
Ethics committee country [1] 286606 0
Australia
Date submitted for ethics approval [1] 286606 0
10/04/2012
Approval date [1] 286606 0
Ethics approval number [1] 286606 0
12/19

Summary
Brief summary
This study will evaluate whether maneuvres to re-inflate collapsed areas of lung during surgery for lung cancer help to improve post-operative oxygen levels.

Who is it for?
You may be eligible to join this study if you are 18 years or above and are scheduled to undergo surgical resection of your lung cancer with one lung ventilation.

Trial details
Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will undergo what is called an alveolar recruitment manoeuvre once during and once following surgery. This involves a brief period of increased airway pressures with the aim of re-inflating collapsed lung units. Participants in the other group will undergo standard treatment with a protective one-lung ventilation strategy. Participants will not know to which group they have been assigned.

Participants will be assessed peri-operatively to compare respiratory outcomes between these two manoeuvres.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33714 0
Address 33714 0
Country 33714 0
Phone 33714 0
Fax 33714 0
Email 33714 0
Contact person for public queries
Name 16961 0
Dr Marissa Ferguson
Address 16961 0
Peter MacCallum Hospital,
St Andrews Place,
East Melbourne,
Victoria 3002
Country 16961 0
Australia
Phone 16961 0
+613 9656 1111
Fax 16961 0
Email 16961 0
marissa.ferguson@gmail.com
Contact person for scientific queries
Name 7889 0
Dr Marissa Ferguson
Address 7889 0
Peter MacCallum Hospital,
St Andrews Place,
East Melbourne,
Victoria 3002
Country 7889 0
Australia
Phone 7889 0
+613 9656 1111
Fax 7889 0
Email 7889 0
marissa.ferguson@gmail.com

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
No additional documents have been identified.