Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001733268
Ethics application status
Approved
Date submitted
12/10/2018
Date registered
22/10/2018
Date last updated
22/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Diaphragm and limb muscle changes during intensive care
Scientific title
DiaphRAgm and SkeleTal muscle changes during Intensive Care: impact on patient functional outcomes
Secondary ID [1] 295878 0
None
Universal Trial Number (UTN)
U1111-1219-3472
Trial acronym
DRASTIC
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Diaphragm changes 309911 0
Musculoskeletal muscle changes 309914 0
Mechanical Ventilation 309915 0
Condition category
Condition code
Respiratory 308695 308695 0 0
Other respiratory disorders / diseases
Musculoskeletal 308696 308696 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An ultrasound will be performed by the principle investigator, a physiotherapist, to assess the morphology, cross sectional area and thickness of the knee extensors (both limbs) and excursion thickness of the diaphragm muscle. The first baseline ultrasound examinations will be performed during the first 24-48 hours of mechanical ventilation (initial assessment). The first follow up will be at Day 5 of mechanical ventilation, then serial measures at Day 7, Day 10 and then weekly. A final examination will be performed up to 72 hours after extubation or liberation from mechanical ventilation for longer than 24 hours.
The following additional data will be collected on every participant (at the same intervals of diaphragm and skeletal muscle ultrasound) to calculate measures of lung function and nutritional status:
- nutritional parameters: feeding route, volume, product, energy and protein provided
- route and mode of mechanical ventilation
- Positive end expiratory pressure (PEEP) in cmH2O from the ventilator
Intervention code [1] 312582 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307669 0
Diaphragm measures of thickness and excursion (composite outcomes) will be collected using ultrasound. This will be achieved by recording still images using a curved probe sub-costally and a linear probe anterolaterally on the chest wall and using digital callipers to measure.
Timepoint [1] 307669 0
Within 24hrs of mechanical ventilation, then on Day 5, 7, 10 and weekly for up to 12 months or until liberation from mechanical ventilation. Diaphragm measurements will also be taken at the point of liberation from mechanical ventilation.
Primary outcome [2] 307670 0
Still images of the rectus femoris muscle will be taken with ultrasound using a linear probe. Composite outcomes of cross sectional area, fascicle length and pennation angle, thickness will be calculated using digital callipers
Timepoint [2] 307670 0
Collected within 24hrs of commencing mechanical ventilation, then on day 5, 7, 10 and weekly for up to 12 months or until liberation from mechanical ventilation. Rectus Femoris measurements will also be taken at the point of liberation from mechanical ventilation.
Secondary outcome [1] 352530 0
ICU acquired Weakness will be measured using the Medical Research Council sum score (MRC-SS). This is a measure of muscle strength (manual muscle test) of major muscle groups, with ICU acquired weakness defined as a score of less than 48/60.
Timepoint [1] 352530 0
Measured at two timepoints: the time of patient awakening and then discharge from ICU
Secondary outcome [2] 352531 0
The Chelsea Critical Care Physical Assessment Tool (CPAx).
This tool measures physical and respiratory function ranging from complete dependence to independent.
Timepoint [2] 352531 0
Measured at the time of patient awakening and at the time of discharge from ICU

Eligibility
Key inclusion criteria
1. Age >18 years
2. Anticipated treatment duration of mechanical ventilation (MV) for more than 48-hours.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with spinal cord injury, other primary neuromuscular diseases or new intracranial processes, amputations, previously wheelchair/bed bound, disseminated cancer and lower limb trauma. Body habitus preventing ultrasound imaging with >40 BMI

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

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Single group
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics are reported as mean and standard deviation (SD) or median and interquartile range (IQR) as appropriate. Changes over time for the ultrasound parameters will be examined using a linear random coefficient regression model. Within the model, an interaction between time and explanatory variables including age, sex, number of days in ICU at time of the first ultrasound measure, number of days on mechanical ventilation and ICU LOS will be examined. Pearson correlation coefficient will be used to assess bivariate relationships between ultrasonography and patient functional outcome measures. Coefficients will be interpreted as little (0.00-0.25), fair (0.25-0.50), moderate (0.50-0.75), and strong (0.75-1.0) association

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/11/2018
Actual
Date of last participant enrolment
Anticipated
17/06/2019
Actual
Date of last data collection
Anticipated
1/07/2019
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12105 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 24267 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 300475 0
Hospital
Name [1] 300475 0
St Vincent's Hospital Sydney - Professor Anthony Schembri
Country [1] 300475 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
390 Victoria Street
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 299943 0
None
Name [1] 299943 0
Address [1] 299943 0
Country [1] 299943 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301277 0
St Vincent's Hospital HREC (EC00140)
Ethics committee address [1] 301277 0
Ethics committee country [1] 301277 0
Australia
Date submitted for ethics approval [1] 301277 0
08/03/2018
Approval date [1] 301277 0
26/07/2018
Ethics approval number [1] 301277 0
HREC/18/SVH/50

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

Contacts
Principal investigator
Name 86458 0
Dr George Ntoumenopoulos
Address 86458 0
St Vincent's Hospital
Physiotherapy Department
390 Victoria Street
Darlinghurst NSW 2010
Country 86458 0
Australia
Phone 86458 0
+61434762167
Fax 86458 0
Email 86458 0
[email protected]
Contact person for public queries
Name 86459 0
George Ntoumenopoulos
Address 86459 0
St Vincent's Hospital
Physiotherapy Department
390 Victoria Street
Darlinghurst NSW 2010
Country 86459 0
Australia
Phone 86459 0
+61434762167
Fax 86459 0
Email 86459 0
[email protected]
Contact person for scientific queries
Name 86460 0
George Ntoumenopoulos
Address 86460 0
St Vincent's Hospital
Physiotherapy Department
390 Victoria Street
Darlinghurst NSW 2010
Country 86460 0
Australia
Phone 86460 0
+61434762167
Fax 86460 0
Email 86460 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23674Study protocol  [email protected]

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.