Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001009707
Ethics application status
Approved
Date submitted
25/06/2022
Date registered
19/07/2022
Date last updated
24/03/2024
Date data sharing statement initially provided
19/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The relationship between lung ultrasound imaging and oxygenation during alveolar recruitment manoeuvres in neonates receiving high frequency oscillatory ventilation.
Scientific title
The relationship between lung ultrasound imaging and oxygenation during alveolar recruitment manoeuvres in neonates receiving high frequency oscillatory ventilation.
Secondary ID [1] 307433 0
None
Universal Trial Number (UTN)
Trial acronym
LUNAR: Lung ultrasound during alveolar recruitment manoeuvres
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal respiratory distress 326800 0
Lung recruitment 326801 0
Condition category
Condition code
Respiratory 324017 324017 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 324047 324047 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Infants who are ventilated on high frequency oscillatory ventilation (HFOV) will receive an oxygenation guided alveolar recruitment manoeuvre (ARM) if deemed appropriate and required by the treating team. ARMs are standard procedure when practicing open lung protective ventilation strategies. The number of increments of the ARM will vary as it is guided by the infants response to the procedure. Lung ultrasound (LUS) will be performed at each step of the recruitment manoeuvre. The number of ultrasound will vary depending on number of steps in the recruitment manoeuvre. This is anticipated to be between 5 to 15. Each ultrasound is anticipated to take 3 minutes. If a system is available, electrical impedance tomography (EIT) will be performed to concurrently measure end expiratory lung volume (EELV) throughout the manoeuvre. Ultrasound and EIT findings will not be used to guide clinical treatment and the treating team will be blinded to the findings. Demographic data, ventilation and physiological parameters will be collected during the ARM period. No follow up data will be collected.
Intervention code [1] 323873 0
Diagnosis / Prognosis
Comparator / control treatment
The lung ultrasound images will be blindly reported and assigned an aeration score which will be compared to the saturation to S/F ratio and other markers of lung recruitment as described below.
Control group
Active

Outcomes
Primary outcome [1] 331809 0
LUS scores during the ARM which will be blindly reported by the study investigators
Timepoint [1] 331809 0
At each increment of the ARM
Secondary outcome [1] 411238 0
End expiratory lung volume (EELV) determined using EIT


Timepoint [1] 411238 0
At each increment of the ARM
Secondary outcome [2] 411362 0
SpO2 measured by pulse oximetry
Timepoint [2] 411362 0
At each increment of the ARM
Secondary outcome [3] 411363 0
Mean airway pressure measured by the ventilator
Timepoint [3] 411363 0
At each increment of the ARM
Secondary outcome [4] 411364 0
Oxygen saturation index (OSI) which will be determined by the measured SpO2 and fraction of inspired oxygen
Timepoint [4] 411364 0
At each increment of the ARM
Secondary outcome [5] 411365 0
Fraction of inspired oxygen (FiO2) as measured by the ventilator
Timepoint [5] 411365 0
At each increment of the ARM
Secondary outcome [6] 411366 0
Tidal volume as measured by the ventilator
Timepoint [6] 411366 0
At each increment of the ARM
Secondary outcome [7] 411367 0
Oscillatory amplitude as measured by the ventilator
Timepoint [7] 411367 0
At each increment of the ARM
Secondary outcome [8] 411368 0
Carbon dioxide diffusion coefficient (DCO2) as measured by the ventilator
Timepoint [8] 411368 0
At each increment of the ARM
Secondary outcome [9] 411369 0
Transcutaneous partial pressure of carbon dioxide (TCO2) as measured from the monitoring systems
Timepoint [9] 411369 0
At each increment of the ARM
Secondary outcome [10] 411370 0
Transcutaneous partial pressure of oxygen (TO2) as measured from the monitoring systems
Timepoint [10] 411370 0
At each increment of the ARM

Eligibility
Key inclusion criteria
All infants who are on HFOV less than or equal to 0.3 FiO2 with recruitable lung disease. This includes but is not limited to:

• Respiratory distress syndrome related to surfactant deficiency
• Acute respiratory distress syndrome secondary to acquired lung inflammation
• Meconium aspiration syndrome
• Pneumonia
• Preterm infants post abdominal surgery
Minimum age
No limit
Maximum age
4 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any infant in which alveolar recruitment would be contra-indicated, these include:

• Clinician concern regarding clinical stability
• Primary pulmonary hypertension without parenchymal lung disease
• Congenital lung malformations including congenital diaphragmatic hernia
• Pulmonary hypoplasia
• Cystic chronic lung disease
• Air leak including pneumothorax and pulmonary interstitial emphysema
• Hydrops fetalis or large pleural effusions
• Hypotensive despite appropriate cardiovascular support
• Skin integrity will not tolerate ultrasound gel

Study design
Purpose
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Sample size:

As this is an exploratory descriptive study and accounting for feasibility considerations, we will recruit a convenience sample of 20 infants. This was the intended sample size for previous studies of open lung ventilation and meaningful data was obtained from 12 – 15 patients.

Descriptive Statistics:

Baseline demographic characteristics including gestational age, corrected age at study entry, birth weight, current weight, ventilation requirements and antenatal history will be presented as means and standard deviation of the mean or median and interquartile range if normally or non-normally distributed.

Primary outcome:

To evaluate the relationship between the LUS scores and S/F ratio the PV curves constructed from each measurements will be visually inspected. Hysteresis will be defined as the presence of distinct inflation and deflation limbs and higher LUS scores seen during the deflation limbs when compared to the corresponding points on the inflation limb. The proportion of infants where pulmonary hysteresis is detected by LUS will be reported. Curves will be inspected for key points of the PV relationship including opening and closing pressure defined by the maximal inflection points on the inflation and deflation limbs respectively.

Secondary outcome:

Respective PV curves derived from each of the surrogate indicators of lung volume will be visually inspected for distinct inflation and deflation limbs, hysteresis and opening and closing pressures. The relationship between these points between each parameters will then be described.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
18/01/2023
Date of last participant enrolment
Anticipated
1/08/2024
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
20
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22619 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 22620 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [3] 22621 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 37884 0
3052 - Parkville
Recruitment postcode(s) [2] 37885 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 311706 0
Government body
Name [1] 311706 0
National Health and Medical Research Council
Country [1] 311706 0
Australia
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
20 Flemington Road, Parkville Victoria 3052
Country
Australia
Secondary sponsor category [1] 313162 0
None
Name [1] 313162 0
NA
Address [1] 313162 0
NA
Country [1] 313162 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311158 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 311158 0
Ethics committee country [1] 311158 0
Australia
Date submitted for ethics approval [1] 311158 0
20/06/2022
Approval date [1] 311158 0
26/09/2022
Ethics approval number [1] 311158 0
HREC/84986/RCHM - 2022

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

Contacts
Principal investigator
Name 120150 0
Dr Arun Sett
Address 120150 0
The Royal Women's Hospital
20 Flemington Road, Parkville, Victoria 3052
Country 120150 0
Australia
Phone 120150 0
+61383453763
Fax 120150 0
Email 120150 0
[email protected]
Contact person for public queries
Name 120151 0
Arun Sett
Address 120151 0
The Royal Women's Hospital
20 Flemington Road, Parkville, Victoria 3052
Country 120151 0
Australia
Phone 120151 0
+61383453763
Fax 120151 0
Email 120151 0
[email protected]
Contact person for scientific queries
Name 120152 0
Arun Sett
Address 120152 0
The Royal Women's Hospital
20 Flemington Road, Parkville, Victoria 3052
Country 120152 0
Australia
Phone 120152 0
+61383453763
Fax 120152 0
Email 120152 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?
Fully de-identified participant data that underlie the results reported
When will data be available (start and end dates)?
6 months following article publication indefinitely
Available to whom?
Investigators from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee, and prospective written consent has been sought from the CPI.
Available for what types of analyses?
Investigators from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee, and prospective written consent has been sought from the CPI.
How or where can data be obtained?
Through direct contact with the CPI

Dr Arun Sett
[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.