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Trial registered on ANZCTR


Registration number
ACTRN12617001280392
Ethics application status
Approved
Date submitted
30/08/2017
Date registered
6/09/2017
Date last updated
3/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Lung Ultrasound in patients on Veno-Venous ExtraCorporeal Membrane Oxygenation (LUVVECMO)
Scientific title
Diagnostic Lung Ultrasound in comparison to standard assessments for mechanically ventilated patients on Veno-Venous ExtraCorporeal Membrane Oxygenation (LUVVECMO)
Secondary ID [1] 292777 0
None
Universal Trial Number (UTN)
U1111-1201-4818
Trial acronym
LUVVECMO (Lung Ultrasound in patients on Veno-Venous ExtraCorporeal Membrane Oxygenation)
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Respiratory 304568 0
Extracorporeal membrane oxygen support 304571 0
Mechanical ventilation
304576 0
Condition category
Condition code
Respiratory 303900 303900 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnostic lung ultrasound (LUS) will be conducted within 48-hours of commencement of extracorporeal membrane oxygenation (ECMO), then again on day 5 and day 10 after the commencement of ECMO (or on the day of ECMO de-cannulation). The diagnostic lung ultrasound will be performed by a trained physiotherapist. The patient will be imaged in supine with the head of bed elevated 30-45 degrees dependent on device/patient stability. The intensive care unit has a dedicated portable ultrasound unit (Sonosite Edge) and for this study the convex array probe (3 to 5 MHz) will be used.
Intervention code [1] 299010 0
Diagnosis / Prognosis
Comparator / control treatment
The daily CXR is a standard of care in intensive care. The CXR will be reported by the intensivist (blinded to LUS findings) with each hemithorax divided into 2 zones (upper and lower zones) and the number of zones (out of 4) for the presence infiltrates/opacification, pleural effusion and/or pneumothorax will be reported based on the Murray Lung Injury Score.
The routine data collected as part of standard care at the same intervals as LUS will be used to calculate measures of lung function and include:
• Partial pressure of arterial oxygen/Fraction of inspired oxygen (PaO2/FIO2) in mmHg, routinely taken from the arterial blood gases that are part of standard patient care will be taken with the FIO2 on the ventilator as clinically indicated.
• Positive end expiratory pressure (PEEP) in CMH2O from the ventilator
• Lung Compliance measure from monitored values taken from the mechanical ventialtor display screen (in ml/CMH2O, only if the patient is in a mandatory mode of mechanical ventilation). The compliance may be calculated as follows: TV/PIP-PEEP, where TV is Tidal Volume, and PIP is Peak Inspiratory Pressure, only when in mandatory modes of mechanical ventilation. Mechanical ventilation parameters will be documented at the same time points as LUS immediately prior to LUS assessment, to allow the calculation of dynamic lung compliance (Tidal volume/Peak pressure-PEEP) and driving pressure (Peak pressure-PEEP).


Control group
Active

Outcomes
Primary outcome [1] 303244 0
Lung ultrasound aeration score
Timepoint [1] 303244 0
Up to 48 hours post ECMO insertion then day 5 and day 10 post ECMO insertion
Secondary outcome [1] 338337 0
The daily CXR is a standard of care in intensive care. The CXR will be reported by the intensivist (blinded to LUS findings) with each hemithorax divided into 2 zones (upper and lower zones) and the number of zones (out of 4) for the presence infiltrates/opacification, pleural effusion and/or pneumothorax will be reported based on the Murray Lung Injury Score.
Timepoint [1] 338337 0
Up to 48 hours post ECMO insertion then day 5 and day 10 post ECMO insertion
Secondary outcome [2] 338447 0
Dynamic lung/thorax compliance by calculated Tidal volume/Peak pressure-PEEP values taken from the mechanical ventilator immediately prior to ultrasound imaging.
Timepoint [2] 338447 0
Up to 48 hours post ECMO insertion then day 5 and day 10 post ECMO insertion
Secondary outcome [3] 338527 0
Partial pressure of arterial oxygen/Fraction of inspired oxygen (PaO2/FIO2) in mmHg, routinely taken from the arterial blood gases that are part of standard patient care will be taken with the FIO2 on the ventilator as clinically indicated.
Timepoint [3] 338527 0
Up to 48 hours post ECMO insertion then day 5 and day 10 post ECMO insertion
Secondary outcome [4] 338528 0
Ventilator driving pressure taken from the mechanical ventilator (difference between the peak airway pressure and positive end expiratory pressure in cmH20) only calculated with the patient in a mandatory mode of mechanical ventilation immediately prior to ultrasound imaging..
Timepoint [4] 338528 0
Up to 48 hours post ECMO insertion then day 5 and day 10 post ECMO insertion

Eligibility
Key inclusion criteria
1. Age>18 years
2. Require veno-venous ECMO
3. Patient/next of kin willingness to give written informed consent and willingness to participate in and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to maintain patient position required for optimum ultrasound imaging
2. Body habitus prevents optimum ultrasound imaging

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

Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
This is an observational cohort study with descriptive variables. A pilot sample size of 10 has been selected based on an expected accrual of patients who require VV-ECMO over a 24-month period. At each time we will compared the LUS score of aeration with the dynamic compliance, ventilator driving pressure, CXR score to predict the de-cannulation time for patients on VV-ECMO. ROC curves will be used to determine the most significant predictors of liberation and survival from ECMO. Optimal cut-points which maximise the true positive rate for each predictor will be obtained.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8916 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 17287 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 297407 0
Charities/Societies/Foundations
Name [1] 297407 0
Extracorpreal Life Support Organisation
Address [1] 297407 0
2800 Plymouth Rd, Building 300, Room 303, Ann Arbor, Michigan 48109-2800
Country [1] 297407 0
United States of America
Primary sponsor type
Individual
Name
George Ntoumenopoulos
Address
Physiotherapy Department
St Vincent's Hospital
390 Darlinghurst Road
Darlinghurst Sydney
NSW 2010
Country
Australia
Secondary sponsor category [1] 296397 0
Hospital
Name [1] 296397 0
St Vincent's Hospital
Address [1] 296397 0
390 Darlinghurst Road
Darlinghurst Sydney
NSW 2010
Country [1] 296397 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298512 0
St Vincent's Hospital HREC (EC00140)
Ethics committee address [1] 298512 0
St Vincent's Hospital Research Office
Translational Research Centre
97-105 Boundary Street
Darlinghurst 2010
NSW
Sydney
Ethics committee country [1] 298512 0
Australia
Date submitted for ethics approval [1] 298512 0
06/04/2017
Approval date [1] 298512 0
20/06/2017
Ethics approval number [1] 298512 0
HREC/17/SVH/118

Summary
Brief summary
Hypothesis: Diagnostic lung ultrasound may be a useful non-invasive bedside tool to assist with clinical decision making during veno-venous-extracorporeal membrane oxygen support and requires further investigation.
Objectives
Primary: Can diagnostic lung ultrasound be used to monitor the movement of air in the lungs of patients who require on veno-venous ECMO?
Secondary: To study the changes of in the movement of air in the lungs using lung ultrasound in comparison to standard measures of lung function and chest X-ray changes up to the point of weaning a patient from extra-corporeal membrane oxygenation
Study design
Prospective observational cohort study of 10 patients
LUS assessment will be undertaken within 48-hours after commencement of ECMO and at 5 and 10 days after ECMO commencement. Standard measurements for VV-ECMO, including ECMO settings (sweep flow, ECMO flow) and arterial blood gases will be undertaken 4-6 hourly and recorded. The portable anterior chest radiograph will undertaken once per day and as clinically indicated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77314 0
A/Prof George Ntoumenopoulos
Address 77314 0
Physiotherapy Department
St Vincent's Hospital
390 Darlinghurst Road
Darlinghurst
Sydney 2010
NSW
Country 77314 0
Australia
Phone 77314 0
+61434762167
Fax 77314 0
Email 77314 0
George.Ntoumenopoulos@svha.org.au
Contact person for public queries
Name 77315 0
A/Prof George Ntoumenopoulos
Address 77315 0
Physiotherapy Department
St Vincent's Hospital
390 Darlinghurst Road
Darlinghurst
Sydney 2010
NSW
Country 77315 0
Australia
Phone 77315 0
+61434762167
Fax 77315 0
Email 77315 0
George.Ntoumenopoulos@svha.org.au
Contact person for scientific queries
Name 77316 0
A/Prof George Ntoumenopoulos
Address 77316 0
Physiotherapy Department
St Vincent's Hospital
390 Darlinghurst Road
Darlinghurst
Sydney 2010
NSW
Country 77316 0
Australia
Phone 77316 0
+61434762167
Fax 77316 0
Email 77316 0
George.Ntoumenopoulos@svha.org.au

No data has been provided for results reporting
Summary results
Not applicable