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Trial registered on ANZCTR
Registration number
ACTRN12614000790640
Ethics application status
Approved
Date submitted
19/07/2014
Date registered
24/07/2014
Date last updated
13/08/2019
Date data sharing statement initially provided
5/04/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
A Prospective Randomised Trial of Two Tidal Volume Ventilator Strategies in Patients Undergoing Major Surgery
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Scientific title
A prospective randomised trial of intraoperative tidal volume ventilation with 6ml/kg (Ideal Body weight) and positive end expiratory pressure (PEEP) of 5 cm H2O versus 10ml/kg (Ideal Body weight) and PEEP of 5 cm H2O, in adult patients undergoing major surgery.
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Secondary ID [1]
285016
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None
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Universal Trial Number (UTN)
U1111-1159-4667
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Trial acronym
Not applicable
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Effects of ventilation in patients undergoing major surgery
292530
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Condition category
Condition code
Anaesthesiology
292834
292834
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0
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Anaesthetics
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Surgery
292835
292835
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0
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Other surgery
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Respiratory
292836
292836
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
In patients undergoing major surgery who mechanical ventilation patients with an endotracheal tube, the ventilation strategy will be randomised to compare either a 6ml/kg or 10ml/kg tidal volume strategy in combination with PEEP.
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Intervention code [1]
289850
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Treatment: Devices
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Comparator / control treatment
Both group will receive the intervention; the ventilation strategy will either a 6ml/kg or 10ml/kg tidal volume in combination with PEEP.
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Control group
Dose comparison
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Outcomes
Primary outcome [1]
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The number of patients with a postoperative pulmonary complication. Pulmonary complications include pneumonia, bronchospasm, atelectasis, pulmonary congestion, pulmonary embolism, respiratory failure and requirements for mechanical ventilation, pleural effusion and pneumothorax.
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Assessment method [1]
292701
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Timepoint [1]
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Within the first 7 days after surgery
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Secondary outcome [1]
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Requirements for post-operative Intensive Care
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Assessment method [1]
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Timepoint [1]
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Duration of hospital stay
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Secondary outcome [2]
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Number of hours in ICU
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Assessment method [2]
309521
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Timepoint [2]
309521
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Duration of ICU stay
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Secondary outcome [3]
309523
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30 day mortality
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Assessment method [3]
309523
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Timepoint [3]
309523
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30 days postoperatively
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Secondary outcome [4]
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Incidence of each individual component of the primary composite outcome
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Assessment method [4]
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Timepoint [4]
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Duration of hospital stay
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Secondary outcome [5]
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Incidence of postoperative respiratory complications
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Assessment method [5]
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Timepoint [5]
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Duration of hospital stay
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Secondary outcome [6]
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Incidence of pulmonary embolism
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Assessment method [6]
373813
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Timepoint [6]
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At 7 post operative days and during hospital length of stay
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Secondary outcome [7]
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Incidence of systemic inflammatory response syndrome
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Assessment method [7]
373814
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Timepoint [7]
373814
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At 7 post operative days and during hospital length of stay
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Secondary outcome [8]
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Incidence of sepsis
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Assessment method [8]
373815
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Timepoint [8]
373815
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At 7 post operative days and during hospital length of stay
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Secondary outcome [9]
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Incidence of wound infection (superficial and deep)
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Assessment method [9]
373816
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Timepoint [9]
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At 7 post operative days and during hospital length of stay
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Secondary outcome [10]
373817
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Rate of intraoperative need of vasopressor
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Assessment method [10]
373817
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Timepoint [10]
373817
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At 7 post operative days and during hospital length of stay
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Secondary outcome [11]
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Incidence of unplanned intensive care unit (ICU) admission
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Assessment method [11]
373818
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Timepoint [11]
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Duration of hospital length of stay
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Secondary outcome [12]
373819
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Rate of need for medical emergency team call
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Assessment method [12]
373819
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Timepoint [12]
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Duration of hospital length of stay
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Secondary outcome [13]
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Incidence of in-hospital mortality
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Assessment method [13]
373820
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Timepoint [13]
373820
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Duration of hospital length of stay
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Eligibility
Key inclusion criteria
Patients will be eligible to participate in this study if:
1. The patient is aged 40 years or older
2. The treating anaesthetist expects that the patient will remain intubated for a period of equal to or greater than two hours
3. The patient will have an arterial line inserted for routine monitoring of blood pressure during the surgical procedure
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Minimum age
40
Years
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Maximum age
No limit
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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
Patients will be ineligible for participation if:
1. The patient is pregnant and/or lactating
2. The patient has planned thoracic surgery
3. The patient has planned cardiac surgery
4. The patient has planned intracranial neurosurgery
5. Previously enrolment in this Trial
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Study design
Purpose of the study
Treatment
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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)
All adult patients scheduled to undergoing a major surgical procedure and require mechanical ventilation in the operating suite of the Austin Hospital will be screened for eligibility. Once informed consent has been obtained, randomisation will be by means of sealed opaque envelopes with permuted blocks of variable size. Each envelope will contain a study arm allocation with the tidal volume target as well as a copy of a simplified study protocol.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation will be used using computer generated software.
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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
There are two study groups associated with this trial:
1. Volume control ventilation with a tidal volume 6ml/kg of Ideal Body Weight and PEEP of 5cm H2O.
2. Volume control ventilation with tidal volume 10ml/kg of Ideal Body Weight and PEEP of 5cm H2O.
Calculation of tidal volume & use of PEEP.
Tidal volume for each participant will be calculated base on a) the patient’s gender and b) the patient’s ideal body weight (IBW). IBW will be calculated by the treating anaesthetist using the following standard formula.
For males: 50 + 0.91 (centimetres in height – 152.4)
For females 45.5 + 0.91 (centimetres in height – 152.4)
Immediately after randomisation, the tidal volume will be set on the ventilator for either a target of 6ml/kg or 10 ml/kg based on ideal body weight and gender. This allocated tidal volume target will be maintained for the duration of the surgical procedure. At the end of the surgical procedure the patient will have their anaesthesia reversed and will be woken and weaned from mechanical ventilation according to standard hospital protocol. There is no change to the type of anaesthesia provide or any oxygenation or ventilation management of enrolled patients during the surgical procedures.
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
This is a prospective randomised trial comparing two tidal volume targets in patients undergoing major surgery. Data will be analysed on an intention-to-treat basis. Comparisons will be made using t-test and ANOVA for repeated-measures or Wilcoxon rank-signed test and Kruskall-Wallis according to the underlying distribution for continuous data and Chi-square for categorical data. A Kaplan-Meier curve with log-rank test will be performed to further compare in-hospital mortality and rate of discharge home where appropriate. Logistic regression analysis will also be performed to adjust for baseline imbalances.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/08/2014
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Actual
1/09/2014
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Date of last participant enrolment
Anticipated
30/06/2017
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Actual
21/11/2018
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Date of last data collection
Anticipated
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Actual
21/12/2018
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Sample size
Target
1240
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Accrual to date
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Final
1240
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
2753
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
8452
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
289628
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Hospital
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Name [1]
289628
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Departments of Intensive Care and Anaesthesia, Austin Hospital
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Address [1]
289628
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Studley Road, Heidelberg, Victoria, 3084, Australia
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Country [1]
289628
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Australia
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Primary sponsor type
Hospital
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Name
Departments of Intensive Care and Anaesthesia, Austin Hospital
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Address
Studley Road, Heidelberg, Victoria, 3084, Australia
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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]
288315
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Address [1]
288315
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Country [1]
288315
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
291369
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Research Ethics Unit Austin Health
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Ethics committee address [1]
291369
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Studley Road, Heidelberg, Victoria, 3084, Australia
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Ethics committee country [1]
291369
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Australia
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Date submitted for ethics approval [1]
291369
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Approval date [1]
291369
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14/07/2014
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Ethics approval number [1]
291369
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HREC/14/Austin/260
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Summary
Brief summary
There is no good evidence to guide the choice of breath size (tidal volume) delivered by the breathing machine during anaesthesia. In a recent multi-centre study, we found that anaesthetists deliver a variable tidal volumes with some patients receiving low-tidal volumes (6-7 ml/kg) and others receiving high-tidal volumes (9-10 ml/Kg) according to clinician preference. We also found that they typically positive end expiratory pressure (PEEP) (pressure to keep lung when breathing out has been completed) at an average modest value of 5.0 cmH2O. Thus, in Victoria and the Austin hospital in patients under general anaesthesia administered tidal volume can be variably high or low and PEEP is often applied at modest levels. Because of such variability and the possibility that one approach or another may be better at avoiding lung complications after anaesthesia, we wish to perform prospective randomised trial to evaluate the impact and outcome of two different tidal volume strategies during anaesthesia. Specifically, we wish to conduct a pilot single-centre prospective randomised trial comparing a low tidal volume (6 ml/kg) to a higher tidal volume (10 ml/kg) tidal volume strategy in combination with PEEP at 5 cm H2O for patients undergoing major surgery. The anticipated sample size is 900 participants over a 18 month period. Patients will be randomly allocated to either low or control tidal volume ventilation for the period of their surgical procedure to test the hypothesis that one of these two approaches in superior at decreasing post-surgical lung complications.
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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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Dr Laurence Weinberg
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Address
50066
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Department of Anaesthesia
Austin Hospital, Studley Road, Heidelberg, 3084, Victoria
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Country
50066
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Australia
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Phone
50066
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+61 3 94965000
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Fax
50066
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+61 3 94596421
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Email
50066
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[email protected]
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Contact person for public queries
Name
50067
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Laurence Weinberg
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Address
50067
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Department of Anaesthesia
Austin Hospital, Studley Road, Heidelberg, 3084, Victoria
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Country
50067
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Australia
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Phone
50067
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+61 3 94965000
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Fax
50067
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+61 3 94596421
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Email
50067
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[email protected]
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Contact person for scientific queries
Name
50068
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Laurence Weinberg
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Address
50068
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Department of Anaesthesia
Austin Hospital, Studley Road, Heidelberg, 3084, Victoria
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Country
50068
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Australia
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Phone
50068
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+61 3 94965000
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Fax
50068
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+61 3 94596421
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Email
50068
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Participants have not consented to sharing of their data. Reasonable requests for the de-identified database can me made in writing to the trial Chief Investigator.
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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
Source
Title
Year of Publication
DOI
Embase
Intraoperative low tidal volume ventilation and the risk of ICD-10 coded delirium and the use for antipsychotic medications.
2022
https://dx.doi.org/10.1186/s12871-022-01689-3
Embase
Intra-operative ventilator mechanical power as a predictor of postoperative pulmonary complications in surgical patients: A secondary analysis of a randomised clinical trial.
2022
https://dx.doi.org/10.1097/EJA.0000000000001601
Embase
Low tidal volume ventilation for patients undergoing laparoscopic surgery: a secondary analysis of a randomised clinical trial.
2023
https://dx.doi.org/10.1186/s12871-023-01998-1
N.B. These documents automatically identified may not have been verified by the study sponsor.
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