Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000438954p
Ethics application status
Not yet submitted
Date submitted
31/03/2020
Date registered
6/04/2020
Date last updated
6/04/2020
Date data sharing statement initially provided
6/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Utilizing lung ultrasound in COVID-19 patients in ICU – comparison of management strategies on survival and time on ventilation.
Scientific title
Utilizing lung ultrasound in COVID-19 patients in ICU – comparison of management strategies on survival and time on ventilation.
Secondary ID [1] 300909 0
Nil
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 316844 0
Acute respiratory distress syndrome 316845 0
Pneumonia 316846 0
Condition category
Condition code
Infection 315050 315050 0 0
Other infectious diseases
Respiratory 315091 315091 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
4
Target follow-up type
Weeks
Description of intervention(s) / exposure
Patients with pulmonary infection and COVID 19 will have their respiratory management during ICU admission decided in one of two ways
Method 1. Lung ultrasound will be used to make management decisions - this is a non-invasive way of ultrasounding the lungs
One hospital site will use method 1
Three hospitals will use method 2
Both methods are currently standard at the respective hospitals
The comparator treatment will be decided by the attending intensivist. The treatment will be different in every patient. Depending on the results of the auscultation and waveform analysis, a different method of mechanical ventilation or respiratory physiotherapy may be chosen.

Respiratory physiotherapy may be different in each case but will consist of either ventilator hyperinflation, positioning or manual techniques. The senior respiratory physiotherapist will decide the type of physiotherapy treatment delivered based on COVI 19 guidelines.
This will be from admission to ICU to 28 days post hospital discharge
Intervention code [1] 317226 0
Early Detection / Screening
Intervention code [2] 317249 0
Diagnosis / Prognosis
Comparator / control treatment
Method 2. Management will be decided by using chest x-ray, ventilator readings and auscultation
One hospital site will use method 1
Three hospitals will use method 2. This will be used throughout their admission to ICU.
Both methods are currently standard at the respective hospitals

The comparator treatment will be decided by the assessment above. The treatment will be different in every patient. Depending on the results of the auscultation and waveform analysis, a different method of mechanical ventilation or respiratory physiotherapy may be chosen
This will be from admission to ICU to 28 days post hospital discharge
Control group
Active

Outcomes
Primary outcome [1] 323356 0
Mortality
Timepoint [1] 323356 0
During Intensive care unit stay < 14 days
Primary outcome [2] 323357 0
Mortality
Timepoint [2] 323357 0
28 day post discharge from ICU
Primary outcome [3] 323358 0
Length of stay intensive care unit from patient medical record
Timepoint [3] 323358 0
Discharge from intensive care
Secondary outcome [1] 381643 0
Length of hospital stay from patient medical records
Timepoint [1] 381643 0
At hospital discharge
Secondary outcome [2] 381644 0
Time on ventilator from patient medical records
Timepoint [2] 381644 0
On removal from ventilator
Secondary outcome [3] 381645 0
Ventilator free days from patient medical records
Timepoint [3] 381645 0
On discharge from intensive care
Secondary outcome [4] 381646 0
Static compliance of the lung - the mechanical ventilator has an automatic function which provides an inspiratory hold and measures static compliance proving a figure.
Timepoint [4] 381646 0
Before and immediately after then at 10 and 30 minutes post routine physiotherapy treatment
Secondary outcome [5] 381647 0
PaO2/FiO2 this is taken from the arterial blood gas PaO2 divided by the fraction of inspired oxygen.
Timepoint [5] 381647 0
Immediately before and post, then 10 and 30 minutes post physiotherapy treatment

Eligibility
Key inclusion criteria
Positive for COVID 19 with pulmonary involvement - severe
Admission or being considered for admission to intensive care unit
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Moribund or for palliative care

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
1. A t-test for unmatched groups will compare days on ventilation, ventilator free days, length of stay (hospital and ICU) between St .Vincent’s Hospital and the other three hospitals to investigate whether adding LUS to the assessment criteria improved outcome. A chi-square will compare rates of ventilation between groups, mortality (ICU and 28 day) between the two groups and a Kaplan Meir curve will investigate time until death.

2. Measurements PaO2/FiO2 ratio, static compliance (Cstat), will be compared at the four time points by an ANOVA during all routine physiotherapy management in these patients.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/04/2020
Actual
Date of last participant enrolment
Anticipated
30/09/2020
Actual
Date of last data collection
Anticipated
31/10/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
Recruitment hospital [1] 16184 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 16185 0
The Canberra Hospital - Garran
Recruitment hospital [3] 16186 0
The Prince Charles Hospital - Chermside
Recruitment hospital [4] 16187 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 29727 0
4029 - Herston
Recruitment postcode(s) [2] 29728 0
2605 - Garran
Recruitment postcode(s) [3] 29729 0
4032 - Chermside
Recruitment postcode(s) [4] 29730 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 305356 0
University
Name [1] 305356 0
Griffith University
Country [1] 305356 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Griffith University
Nathann Campus
170 Kessels Rd
Nathan QLD 4111
Country
Australia
Secondary sponsor category [1] 305729 0
Hospital
Name [1] 305729 0
Royal Brisbane & Womens Hospital
Address [1] 305729 0
Butterfield St
Herston
Brisbane QLD 4029
Country [1] 305729 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305689 0
Royal Brisbane & Womens Hospital HREC
Ethics committee address [1] 305689 0
Ethics committee country [1] 305689 0
Australia
Date submitted for ethics approval [1] 305689 0
08/04/2020
Approval date [1] 305689 0
Ethics approval number [1] 305689 0

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

Contacts
Principal investigator
Name 101234 0
A/Prof Jennifer Paratz
Address 101234 0
Griffith University
Allied Health
Gold Coast Campus
Parkland Road
Southport
QLD 4215
Country 101234 0
Australia
Phone 101234 0
+61 0736462581
Fax 101234 0
Email 101234 0
[email protected]
Contact person for public queries
Name 101235 0
Jennifer Paratz
Address 101235 0
Griffith University
Allied Health
Gold Coast Campus
Parkland Road
Southport
QLD 4215
Country 101235 0
Australia
Phone 101235 0
+61 0736462581
Fax 101235 0
Email 101235 0
[email protected]
Contact person for scientific queries
Name 101236 0
Jennifer Paratz
Address 101236 0
Griffith University
Allied Health
Gold Coast Campus
Parkland Road
Southport
QLD 4215
Country 101236 0
Australia
Phone 101236 0
+61 0736462581
Fax 101236 0
Email 101236 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Mortality
When will data be available (start and end dates)?
From December 2020 to December 2025
Available to whom?
Intensive Care Community
Australian & New Zealand Intensive Care Society
Available for what types of analyses?
Mult-centre analysis, world wide analysis
How or where can data be obtained?
De-identified from chief investigator
[email protected]


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.