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Trial registered on ANZCTR
Registration number
ACTRN12623000794606
Ethics application status
Approved
Date submitted
28/06/2023
Date registered
25/07/2023
Date last updated
25/07/2023
Date data sharing statement initially provided
25/07/2023
Date results information initially provided
25/07/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
Examination of respiratory mechanics with trunk inclination in obese and non-obese ARDS patients
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Scientific title
Examination of respiratory mechanics with trunk inclination in obese and non-obese ARDS patients
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Secondary ID [1]
310003
0
None
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Universal Trial Number (UTN)
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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:
ARDS
330502
0
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Condition category
Condition code
Respiratory
327347
327347
0
0
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Other respiratory disorders / diseases
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Diet and Nutrition
327452
327452
0
0
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention - Trunk inclination (40 degree and zero degree) in a randomized cross over design in obese and non-obese mechanically ventilated ARDS patients.
This will be done using the ICU bed controls by the treating physician
Each inclination will be done for 15 minutes before the measurements (lung mechanics and blood gases) are done.
Each inclination (either 40 degree and zero degree) will be maintained for 15 minutes and both inclinations will be tested within the same session
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Intervention code [1]
326422
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Treatment: Other
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Comparator / control treatment
Obese compared with non obese group
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Control group
Active
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Outcomes
Primary outcome [1]
335219
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Partition respiratory mechanics -Elastance using the ventilator and the method described by Stenqvist et al (Intensive Care Med (2015) 41:1110–1113)
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Assessment method [1]
335219
0
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Timepoint [1]
335219
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15-minute post intervention completion
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Primary outcome [2]
335433
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Partition respiratory mechanics -driving pressure using the ventilator and the method described by Stenqvist et al (Intensive Care Med (2015) 41:1110–1113)
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Assessment method [2]
335433
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Timepoint [2]
335433
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15 minutes post intervention completion
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Secondary outcome [1]
424232
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Gas exchange (Arterial blood gas- PaO2)
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Assessment method [1]
424232
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Timepoint [1]
424232
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15 minutes post intervention completion
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Secondary outcome [2]
424507
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Gas exchange (Arterial blood gas- PaCo2)
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Assessment method [2]
424507
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Timepoint [2]
424507
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15 minutes post intervention completion
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Secondary outcome [3]
424508
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Gas exchange (Arterial blood gas- pH)
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Assessment method [3]
424508
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Timepoint [3]
424508
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15 minutes post intervention completion
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Eligibility
Key inclusion criteria
diagnosis of moderate or severe ARDS (Berlin definition), deep sedation, muscle paralysis, volume controlled mechanical ventilation
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Minimum age
18
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
Not ARDS patients
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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)
None
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random generated codes
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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
Crossover
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Other design features
Patients were randomized into two 15-minute steps in which trunk inclination was changed from semi-recumbent (40o head up) to supine-flat (0o), or vice versa
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Continuous variables will be expressed as median (interquartile range (IQR)) or mean (standard deviation (SD)) as appropriate. Paired t test will be used to examine respiratory mechanics and blood gas variables in each group. A P<0.05 will beconsidered statistically significant (IBM SPSS version 27).
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
3/03/2022
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Date of last participant enrolment
Anticipated
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Actual
31/01/2023
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Date of last data collection
Anticipated
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Actual
1/04/2023
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Sample size
Target
40
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
24996
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Flinders Medical Centre - Bedford Park
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Recruitment postcode(s) [1]
40653
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5042 - Bedford Park
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Funding & Sponsors
Funding source category [1]
314177
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Hospital
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Name [1]
314177
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ICU internal funds
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Address [1]
314177
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Dept of ICU
1 Flinders Drive
Flinders Medical Centre
Bedford Park SA 5042
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Country [1]
314177
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Australia
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Primary sponsor type
Hospital
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Name
Flinders Medical Centre
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Address
Dept of ICU
1 Flinders Drive
Flinders Medical Centre
Bedford Park SA 5042
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Country
Australia
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Secondary sponsor category [1]
316097
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None
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Name [1]
316097
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Address [1]
316097
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Country [1]
316097
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313306
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Southern Adelaide Clinical Human Research Ethics Committee
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Ethics committee address [1]
313306
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Flinders Medical Centre
1 Flinders Drive
Bedford Park SA 5042
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Ethics committee country [1]
313306
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Australia
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Date submitted for ethics approval [1]
313306
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Approval date [1]
313306
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01/03/2022
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Ethics approval number [1]
313306
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113.22
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Summary
Brief summary
The aim of our study is to measure the effect of trunk inclination on partition respiratory mechanics and gas exchange in a cohort of obese and non-obese mechanically ventilated ARDS patients.
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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
127674
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Dr Shailesh Bihari
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Address
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Dept of ICU
1 Flinders Drive
Flinders Medical Centre
Bedford Park 5042
SA
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Country
127674
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Australia
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Phone
127674
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+61 8 82044247
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Fax
127674
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Email
127674
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[email protected]
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Contact person for public queries
Name
127675
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Dr Shailesh Bihari
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Address
127675
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Dept of ICU
1 Flinders Drive
Flinders Medical Centre
Bedford Park 5042
SA
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Country
127675
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Australia
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Phone
127675
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+61 8 82044247
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Fax
127675
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Email
127675
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[email protected]
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Contact person for scientific queries
Name
127676
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Dr Shailesh Bihari
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Address
127676
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Dept of ICU
Flinders Medical Centre
1 Flinders Drive
Bedford Park 5042
SA
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Country
127676
0
Australia
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Phone
127676
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+61 8 82044247
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Fax
127676
0
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Email
127676
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Lung mechanics data
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When will data be available (start and end dates)?
Oct 2023 to Oct 2028
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Available to whom?
Researchers
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Available for what types of analyses?
Lung mechanics analysis
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How or where can data be obtained?
Through contact via email -
[email protected]
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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
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Basic results
No
386154-(Uploaded-21-07-2023-20-52-36)-Basic results summary.DOCX
Plain language summary
No
In our cohort of mechanically ventilated obese pat...
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