Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000474954
Ethics application status
Approved
Date submitted
10/04/2020
Date registered
15/04/2020
Date last updated
17/09/2020
Date data sharing statement initially provided
15/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Airway Pressure Release Ventilation for mechanically ventilated patients with COVID-19 in Western Australian Intensive Care Units: an observational study
Scientific title
West Australian Airway Pressure Release Ventilation Study in COVID-19: evaluation of ventilation free survival days
Secondary ID [1] 300987 0
Nil known
Universal Trial Number (UTN)
Trial acronym
WAVES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 (SARS-CoV2) 317022 0
Condition category
Condition code
Infection 315187 315187 0 0
Other infectious diseases
Respiratory 315188 315188 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Airway pressure release ventilation has traditionally been used as a rescue mode of mechanical ventilation for patients with ARDS (acute respiratory distress syndrome), however it may also be beneficial early on in ARDS. It helps with recruitment (opening up) of lungs by having a continuous high level of positive pressure and timed pressure release. Spontaneous breathing is still possible.
The mode of ventilation provided to patients is chosen at the discretion of the treating clinician. Mode of mechanical ventilation received by intubated patients in ICU is being observed from intubation until extubated.
Intervention code [1] 317309 0
Not applicable
Comparator / control treatment
The mode of mechanical ventilation provided to a patient is chosen by the treating clinician. The different modes of ventilation manipulate different parts of the breathing cycle, either focused on using pressure to deliver a breath (pressure controlled ventilation), or delivering a designated volume (spontaneous intermittent mandatory ventilation (SIMV)), or supporting a spontaneous breathing patient (pressure support),
Control group
Active

Outcomes
Primary outcome [1] 323444 0
Ventilation free survival days as assessed by reviewing medical records
Timepoint [1] 323444 0
At 90 days after initiation of mechanical ventilation
Secondary outcome [1] 381965 0
Change in P/F ratio after initiation of mechanical ventilation as assessed by arterial blood gas result and medical record of FiO2 delivered on ventilator
Timepoint [1] 381965 0
At 1, 3 and 7 days.
Secondary outcome [2] 381966 0
Complications from mode of ventilation (pneumothorax) as assessed by review of radiology reports and medical records
Timepoint [2] 381966 0
Any time during mechanical ventilation
Secondary outcome [3] 381967 0
ICU length of stay
Timepoint [3] 381967 0
Assessed up to 90 days post enrolment
Secondary outcome [4] 381968 0
Hospital length of stay
Timepoint [4] 381968 0
Assessed at 90 days post enrolment
Secondary outcome [5] 381969 0
Mortality
Timepoint [5] 381969 0
Any time up to 90 days post enrolment

Eligibility
Key inclusion criteria
Mechanically ventilated
COVID-19 positive
Admitted to Intensive Care Unit in participating Western Australian ICU
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
The Murray Lung Injury score will be used to match patients, and compare the APRV and non-APRV groups. The primary outcome will focus on ventilation-free survival days (within 90 days) between those with and without APRV adjusted for time to initiate APRV (or death / day 90 for those without APRV) from admission to ICU. If sample size allows, further adjustment for baseline characteristics, such as the APACHE score and PaO2/FiO2 ratio, of the two groups will be conducted.
Subgroup analysis will be performed according to 1) ARDS severity 2) early initiation of APRV (within 24 hours of initiation of mechanical ventilation), versus late initiation (after 24 hours of mechanical ventilation)

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
27/04/2020
Actual
28/04/2020
Date of last participant enrolment
Anticipated
Actual
29/05/2020
Date of last data collection
Anticipated
8/03/2021
Actual
Sample size
Target
100
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 16416 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 16417 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 16418 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [4] 16419 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment hospital [5] 16420 0
Rockingham General Hospital - Cooloongup
Recruitment hospital [6] 16421 0
Bunbury Hospital - Bunbury
Recruitment hospital [7] 16422 0
St John of God Midland Public Hospital - Midland
Recruitment hospital [8] 16423 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 29960 0
6009 - Nedlands
Recruitment postcode(s) [2] 29961 0
6000 - Perth
Recruitment postcode(s) [3] 29962 0
6150 - Murdoch
Recruitment postcode(s) [4] 29963 0
6112 - Armadale
Recruitment postcode(s) [5] 29964 0
6168 - Cooloongup
Recruitment postcode(s) [6] 29965 0
6230 - Bunbury
Recruitment postcode(s) [7] 29966 0
6056 - Midland
Recruitment postcode(s) [8] 29967 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 305433 0
Hospital
Name [1] 305433 0
Sir Charles Gairdner Hospital
Country [1] 305433 0
Australia
Funding source category [2] 306773 0
Government body
Name [2] 306773 0
WA Health
Country [2] 306773 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedlands 6009, WA
Country
Australia
Secondary sponsor category [1] 305827 0
None
Name [1] 305827 0
Address [1] 305827 0
Country [1] 305827 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305752 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 305752 0
Ethics committee country [1] 305752 0
Australia
Date submitted for ethics approval [1] 305752 0
10/04/2020
Approval date [1] 305752 0
28/04/2020
Ethics approval number [1] 305752 0
RGS 4003
Ethics committee name [2] 305782 0
Ramsay Health Care WA|SA HREC
Ethics committee address [2] 305782 0
Ethics committee country [2] 305782 0
Australia
Date submitted for ethics approval [2] 305782 0
11/04/2020
Approval date [2] 305782 0
21/04/2020
Ethics approval number [2] 305782 0
2015
Ethics committee name [3] 305783 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [3] 305783 0
Ethics committee country [3] 305783 0
Australia
Date submitted for ethics approval [3] 305783 0
15/04/2020
Approval date [3] 305783 0
28/04/2020
Ethics approval number [3] 305783 0
1670

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

Contacts
Principal investigator
Name 101470 0
A/Prof Matthew Anstey
Address 101470 0
c/ Intensive Care Department
G Block, 4th Floor
Hospital Avenue,
Sir Charles Gairdner Hospital
Nedlands 6009, WA
Country 101470 0
Australia
Phone 101470 0
+61 0409124876
Fax 101470 0
Email 101470 0
matthew.anstey@health.wa.gov.au
Contact person for public queries
Name 101471 0
Matthew Anstey
Address 101471 0
c/ Intensive Care Department
G Block, 4th Floor
Hospital Avenue,
Sir Charles Gairdner Hospital
Nedlands 6009, WA
Country 101471 0
Australia
Phone 101471 0
+61 0409124876
Fax 101471 0
Email 101471 0
matthew.anstey@health.wa.gov.au
Contact person for scientific queries
Name 101472 0
Matthew Anstey
Address 101472 0
c/ Intensive Care Department
G Block, 4th Floor
Hospital Avenue,
Sir Charles Gairdner Hospital
Nedlands 6009, WA
Country 101472 0
Australia
Phone 101472 0
+61 0409124876
Fax 101472 0
Email 101472 0
matthew.anstey@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The investigators will be the custodians of the final trial dataset. No-one outside the trial steering committee will be given access to the data without the permission of the trial steering committee. De-identified data (individual participant data of published results only) may be made available after request to the investigators , with approval of the site ethics departments.
When will data be available (start and end dates)?
Available 18-24 months after publication of the results
End 5 years after publication.
Available to whom?
Researchers who provide a methodologically sound proposal that has been approved by the study steering committee
Available for what types of analyses?
Examples include: meta-analyses. Investigators will consider other applications.
How or where can data be obtained?
Through a signed data sharing agreement and by emailing the principal investigator Dr Anstey.
matthew.anstey@health.wa.gov.au


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
No additional documents have been identified.