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Trial registered on ANZCTR
Registration number
ACTRN12614000226606
Ethics application status
Approved
Date submitted
20/02/2014
Date registered
4/03/2014
Date last updated
4/03/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
Investigation of the effects of anaesthetic choice on ventilation-perfusion scatter and lung gas exchange.
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Scientific title
A parallel group randomised comparison study of the effects of TIVA propofol versus inhalational sevoflurane anaesthesia on lung ventilation-perfusion matching and gas exchange, in patients undergoing general anaesthesia for surgery requiring relacant GA with an arterial line for cardiovascular monitoring.
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Secondary ID [1]
284135
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Nil
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Universal Trial Number (UTN)
U1111-1153-6278
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Impaired lung function under anaesthesia
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Condition category
Condition code
Anaesthesiology
291564
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0
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Anaesthetics
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Respiratory
291565
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0
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Normal development and function of the respiratory system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Total intravenous anaesthesia with propofol, titrated against depth of anaesthesia measured using bisepectral index (BIS 40-60).
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Intervention code [1]
288831
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Treatment: Drugs
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Comparator / control treatment
Inhalational anaesthesia with sevoflurane, titrated against depth of anaesthesia measured using bisepectral index (BIS 40-60).
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in ventilation-perfusion scatter in the lung indexed by the log standard deviation of the distribution of ventilation and blood flow (d log SD) measured using the Multiple Inert Gas Elimination Technique (MIGET).
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Assessment method [1]
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Timepoint [1]
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d log SD between measurement made pre-induction of anaesthesia to 2 hours after induction.
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Secondary outcome [1]
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Blood gas indices of ventilation-perfusion (V/Q) scatter: PaO2, P(A-a)O2, P(A-a)CO2, shunt fraction and deadspace fraction.
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Assessment method [1]
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Timepoint [1]
306951
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Change from measurement made pre-induction of anaesthesia to 2 hours after induction.
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Eligibility
Key inclusion criteria
Patients undergoing general anaesthesia for surgery requiring relacant GA with an arterial line for cardiovascular monitoring.
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Severe impairment of lung function. (FEV1 or FVC less than 30% predicted), or morbid obesity (Body mass index (BMI) greater than 40 kg/m2)
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Bio-equivalence
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Statistical methods / analysis
A relative difference between the Groups in d log SD of 20% or more will be considered significant. Analysis will be done using a t-test for unpaired data.
Similarly, change in PaO2, shunt fraction and deadspace fraction will be calculated and the two groups compared using an unpaired t-test.
The primary endpoint will be comparison of d log SD.
From previously published studies using halothane, a d log SD of 50% above awake baseline values is typical after establishment of anaesthesia, with a range of around 25% either side of this. Using a t-test for unpaired data, at an alpha of 0.05 and a beta of 0.9, 16 patients are required. To allow for multiple comparisons, data from 20 patients is required.
To allow for a smaller change in either ventilation or blood flow distributions, or data loss due to technical or logistic difficulties, data from 24 patients will be collected
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/02/2015
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Australian and New Zealand College of Anaesthetists
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Address [1]
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630 St Kilda Road
Melbourne Vic 3004
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Austin Health
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Address
145 Studley Rd
Heidelberg 3084
VIC
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
287466
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
The relative effects on V/Q matching in the lung of modern inhalational anaesthetics such as sevoflurane have not been compared with those of the intravenous agent propofol. There are potentially important implications for the management of patients with reduced lung function undergoing surgery.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Philip Peyton
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Address
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Dept of Anaesthesia
Austin Health
145 Studley Rd
Heidelberg 3084
VIC
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Country
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Australia
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Phone
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61402282398
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Philip Peyton
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Address
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Dept of Anaesthesia
Austin Health
145 Studley Rd
Heidelberg 3084
VIC
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Country
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Australia
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Phone
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61402282398
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Philip Peyton
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Address
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Dept of Anaesthesia
Austin Health
145 Studley Rd
Heidelberg 3084
VIC
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Country
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Australia
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Phone
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61402282398
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Fax
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Email
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[email protected]
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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
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
3966
Plain language summary
No
For efficient oxygen delivery through the body the...
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4459
Study results article
Yes
06/06/19 Peyton, P. J., Marsh, H., & Thompson, B....
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365836-(Uploaded-28-06-2019-11-53-06)-Journal results publication.pdf
4460
Conference poster
No
Peyton, P. J., Marsh, H., & Thompson, B. R. (2019)...
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4461
Other files
No
Peyton, P. J., Marsh, H., & Thompson, B. R. (2019)...
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Documents added automatically
No additional documents have been identified.
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