Trial Review

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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.
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.
Secondary ID [1] 284135 0
Nil
Universal Trial Number (UTN)
U1111-1153-6278
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impaired lung function under anaesthesia 291219 0
Condition category
Condition code
Anaesthesiology 291564 291564 0 0
Anaesthetics
Respiratory 291565 291565 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Total intravenous anaesthesia with propofol, titrated against depth of anaesthesia measured using bisepectral index (BIS 40-60).
Intervention code [1] 288831 0
Treatment: Drugs
Comparator / control treatment
Inhalational anaesthesia with sevoflurane, titrated against depth of anaesthesia measured using bisepectral index (BIS 40-60).
Control group
Active

Outcomes
Primary outcome [1] 291519 0
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).
Timepoint [1] 291519 0
d log SD between measurement made pre-induction of anaesthesia to 2 hours after induction.
Secondary outcome [1] 306951 0
Blood gas indices of ventilation-perfusion (V/Q) scatter: PaO2, P(A-a)O2, P(A-a)CO2, shunt fraction and deadspace fraction.
Timepoint [1] 306951 0
Change from measurement made pre-induction of anaesthesia to 2 hours after induction.

Eligibility
Key inclusion criteria
Patients undergoing general anaesthesia for surgery requiring relacant GA with an arterial line for cardiovascular monitoring.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Bio-equivalence
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/02/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288767 0
Charities/Societies/Foundations
Name [1] 288767 0
Australian and New Zealand College of Anaesthetists
Country [1] 288767 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Rd
Heidelberg 3084
VIC
Country
Australia
Secondary sponsor category [1] 287466 0
None
Name [1] 287466 0
Address [1] 287466 0
Country [1] 287466 0

Ethics approval
Ethics application status
Approved

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46402 0
A/Prof Philip Peyton
Address 46402 0
Dept of Anaesthesia
Austin Health
145 Studley Rd
Heidelberg 3084
VIC
Country 46402 0
Australia
Phone 46402 0
61402282398
Fax 46402 0
Email 46402 0
phil.peyton@austin.org.au
Contact person for public queries
Name 46403 0
A/Prof Philip Peyton
Address 46403 0
Dept of Anaesthesia
Austin Health
145 Studley Rd
Heidelberg 3084
VIC
Country 46403 0
Australia
Phone 46403 0
61402282398
Fax 46403 0
Email 46403 0
phil.peyton@austin.org.au
Contact person for scientific queries
Name 46404 0
A/Prof Philip Peyton
Address 46404 0
Dept of Anaesthesia
Austin Health
145 Studley Rd
Heidelberg 3084
VIC
Country 46404 0
Australia
Phone 46404 0
61402282398
Fax 46404 0
Email 46404 0
phil.peyton@austin.org.au

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

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Current Study Results
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Update to Study Results
Documents added automatically
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