Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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 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
Scientific title
Examination of respiratory mechanics with trunk inclination in obese and non-obese ARDS patients
Secondary ID [1] 310003 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ARDS 330502 0
Condition category
Condition code
Respiratory 327347 327347 0 0
Other respiratory disorders / diseases
Diet and Nutrition 327452 327452 0 0
Obesity

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 326422 0
Treatment: Other
Comparator / control treatment
Obese compared with non obese group
Control group
Active

Outcomes
Primary outcome [1] 335219 0
Partition respiratory mechanics -Elastance using the ventilator and the method described by Stenqvist et al (Intensive Care Med (2015) 41:1110–1113)
Timepoint [1] 335219 0
15-minute post intervention completion
Primary outcome [2] 335433 0
Partition respiratory mechanics -driving pressure using the ventilator and the method described by Stenqvist et al (Intensive Care Med (2015) 41:1110–1113)
Timepoint [2] 335433 0
15 minutes post intervention completion
Secondary outcome [1] 424232 0
Gas exchange (Arterial blood gas- PaO2)
Timepoint [1] 424232 0
15 minutes post intervention completion
Secondary outcome [2] 424507 0
Gas exchange (Arterial blood gas- PaCo2)
Timepoint [2] 424507 0
15 minutes post intervention completion
Secondary outcome [3] 424508 0
Gas exchange (Arterial blood gas- pH)
Timepoint [3] 424508 0
15 minutes post intervention completion

Eligibility
Key inclusion criteria
diagnosis of moderate or severe ARDS (Berlin definition), deep sedation, muscle paralysis, volume controlled mechanical ventilation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not ARDS patients

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)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random generated codes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
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).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/03/2022
Date of last participant enrolment
Anticipated
Actual
31/01/2023
Date of last data collection
Anticipated
Actual
1/04/2023
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 24996 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 40653 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 314177 0
Hospital
Name [1] 314177 0
ICU internal funds
Country [1] 314177 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Dept of ICU
1 Flinders Drive
Flinders Medical Centre
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 316097 0
None
Name [1] 316097 0
Address [1] 316097 0
Country [1] 316097 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313306 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 313306 0
Ethics committee country [1] 313306 0
Australia
Date submitted for ethics approval [1] 313306 0
Approval date [1] 313306 0
01/03/2022
Ethics approval number [1] 313306 0
113.22

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127674 0
Dr Shailesh Bihari
Address 127674 0
Dept of ICU 1 Flinders Drive Flinders Medical Centre Bedford Park 5042 SA
Country 127674 0
Australia
Phone 127674 0
+61 8 82044247
Fax 127674 0
Email 127674 0
[email protected]
Contact person for public queries
Name 127675 0
Shailesh Bihari
Address 127675 0
Dept of ICU 1 Flinders Drive Flinders Medical Centre Bedford Park 5042 SA
Country 127675 0
Australia
Phone 127675 0
+61 8 82044247
Fax 127675 0
Email 127675 0
[email protected]
Contact person for scientific queries
Name 127676 0
Shailesh Bihari
Address 127676 0
Dept of ICU Flinders Medical Centre 1 Flinders Drive Bedford Park 5042 SA
Country 127676 0
Australia
Phone 127676 0
+61 8 82044247
Fax 127676 0
Email 127676 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers

Conditions for requesting access:
• -

What individual participant data might be shared?
• Lung mechanics data

What types of analyses could be done with individual participant data?
• Lung mechanics analysis

When can requests for individual participant data be made (start and end dates)?
From:
Oct 2023 to Oct 2028

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Through contact via email - [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo Basic results summary.DOCX
Plain language summaryNo In our cohort of mechanically ventilated obese pat... [More Details]

Documents added automatically
No additional documents have been identified.