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Trial registered on ANZCTR


Registration number
ACTRN12624001323516p
Ethics application status
Submitted, not yet approved
Date submitted
16/10/2024
Date registered
31/10/2024
Date last updated
31/10/2024
Date data sharing statement initially provided
31/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring effect of chest physiotherapy in ventilated infants using lung ultrasound (LUS)
Scientific title
Investigating the effect of targeted chest physiotherapy on acute lung collapse in mechanically ventilated neonates using LUS
Secondary ID [1] 313193 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm birth 335485 0
Lung collapse and consolidation 335486 0
Condition category
Condition code
Respiratory 332045 332045 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 332133 332133 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chest physiotherapy (CPT) will form the intervention that will be measured in this study. CPT will consist of a combination of techniques including positioning, cupping, expiratory flow increase techniques such as expiratory vibes and sustained expiratory manoeuvres, and endotracheal suction. Treatments will not be standardised. Instead, they will be individualised to each infant’s assessment findings and presentation to reflect clinical reality. All CPT interventions in the study will be performed by a paediatric physiotherapist trained to work in the NCCU. CPT will occur in the NCCU at the infant's bedside as per usual practice in our unit. The techniques, dosing and position utilised during the CPT intervention will be determined by the physiotherapist based on the presence/ type of pathology seen on chest radiograph (CXR), auscultation findings and LUS findings. This is based on current practice in the NCCU where the research project will take place. No published guidelines or practice recommendations are available in the literature due to the lack of previous research undertaken regarding CPT in the neonatal population. A single episode of CPT intervention will be measured, however infant's may be eligible to be measured on more than one occasion, ie. on multiple consecutive days, providing they meet the inclusion criteria. CPT will continue for as many days as indicated (no maximum time frame), based on the physiotherapist's clinical interpretation of assessment findings (CXR, auscultation and LUS). There is no limit on the age of infants being eligible for this research study if they meet inclusion criteria and are receiving care in the NCCU. CPT effects will be measured using Lung Ultrasound (LUS), auscultation, physiological measurements and where available CXR by comparing baseline/ pre-CPT measurements with immediately post, and 4 hours post, CPT measurements. CPT will be undertaken by the physiotherapist and documented in the infant's medical notes and details of the treatment will be documented as part of the study report form. As CPT will be undertaken only by the physiotherapist, not by any other staff members, no adherence strategies will be required.
Intervention code [1] 329765 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339655 0
Change in lung collapse on Lung Ultrasound (LUS)
Timepoint [1] 339655 0
LUS and LUS score will be completed immediately prior to undertaking CPT intervention, again immediately after completion of CPT intervention, and again at 4 hours after completion of CPT intervention.
Secondary outcome [1] 440763 0
Change in auscultation score
Timepoint [1] 440763 0
Auscultation, and auscultation scores, will be collected immediately prior to CPT, immediately after CPT and again at 4 hours post CPT.
Secondary outcome [2] 440764 0
Change in CXR score (if available as part of medical care) with CXR score being a measure of the extent of lung collapse/ how much lung is collapsed, as per the categorization below in Assessment method
Timepoint [2] 440764 0
CXR scores will be made using the most recent formally reported CXR prior to these time points and the details of these CXR will be documented.
Secondary outcome [3] 440971 0
Changes in set Tidal volume or Inspiratory pressure (depending on whether infant is ventilated on a volume mode or a pressure mode)
Timepoint [3] 440971 0
Tidal volume/ set inspiratory pressure be collected immediately prior to CPT, immediately after, and at 4 hours post CPT
Secondary outcome [4] 440972 0
Changes in Fraction of inspired oxygen (FiO2)
Timepoint [4] 440972 0
FiO2 will be recorded immediately prior to CPT, immediately after CPT and at 4 hours after the completion of CPT
Secondary outcome [5] 440973 0
Changes in oxygen saturations (SpO2)
Timepoint [5] 440973 0
SpO2 will be recorded immediately prior to CPT, immediately after CPT and at 4 hours after the completion of CPT
Secondary outcome [6] 440975 0
Changes in transcutaneous carbon dioxide level (TCO2) where available (if being used with infant at the time of CPT)
Timepoint [6] 440975 0
TCO2 will be recorded immediately prior to CPT, immediately after CPT and at 4 hours after the completion of CPT

Eligibility
Key inclusion criteria
i. Neonates < 39 weeks gestational age
ii. Invasively ventilated, receiving care in Mater NCCU
iii. Chest radiograph in previous 24 hours of undertaking CPT and evidence of lung collapse/ consolidation diagnosed by radiographer.
iv. Parent/ guardian written consent.
v. Infant deemed medically safe to undergo CPT interventions.
Minimum age
23 Weeks
Maximum age
39 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Contraindication to CPT
ii. Absence of CXR within 24 hours from time of CPT assessment and treatment
iii. LUS not possible (e.g. Poor skin integrity, dressings, drains etc)
iv. Pending or active redirection of care

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



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317640 0
Other
Name [1] 317640 0
Mater Research
Country [1] 317640 0
Australia
Primary sponsor type
Individual
Name
Bronagh McAlinden - Mater Hospital Brisbane
Address
Country
Australia
Secondary sponsor category [1] 319954 0
Individual
Name [1] 319954 0
Judith Hough - Mater Hospital Brisbane
Address [1] 319954 0
Country [1] 319954 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316338 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 316338 0
http://www.materresearch.org.au/about-us/human-research-ethics-and-governance/human-research-ethics
Ethics committee country [1] 316338 0
Australia
Date submitted for ethics approval [1] 316338 0
24/10/2024
Approval date [1] 316338 0
Ethics approval number [1] 316338 0

Summary
Brief summary
Chest physiotherapy (CPT) is regarded as an important contributor to the management, and potentially long-term outcomes, of preterm infants with lung disease. Delivering CPT in this population is not without risk, however, and the decision to undertake CPT interventions rely on effective assessment (Hough, 2008). Preterm infants present with multiple lung pathologies, (Gallacher et al, 2016) however not all of these are best treated using CPT. In preterm infants, CPT is thought to be most efficacious in treating alveolar collapse and consolidation, and not useful, or potentially harmful, in the management of interstitial lung disease (Hough, 2008). Differentiating between pathological processes using existing assessment tools such as auscultation and chest radiograph is challenging as these tools only provide subjective, non-specific and surrogate measurements of lung aeration and pathology (McAlinden et al, 2020).
Physiotherapy- led lung ultrasound (LUS) has been recently proposed as a more accurate and objective way to image both regional lung aeration and lung pathology by the bedside without the potentially harmful radiation associated with other imaging techniques (Hansell et al, 2023; Hayward et al, 2021). Such imaging makes it theoretically possible to deliver individualised and targeted CPT, thereby improving effectiveness and minimising physiological burden. (Le Neindre et al, 2023) Despite its promise, physiotherapist-led LUS is considered an extended scope skill in Australia and further training and knowledge is required before it can be used safely and effectively. To date, physiotherapist-led LUS has been investigated in paediatric (Myszkowski, 2019; Shkurka & Nolann 2023) and adult cohorts (Hansell et al, 2023; Le Neindre et al, 2023) but similar research has yet to be undertaken in preterm infants. This study aims to investigate the use of LUS as a neonatal physiotherapy assessment tool to measure the effect of CPT in premature infants with lung collapse.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137578 0
Ms Bronagh McAlinden
Address 137578 0
Physiotherapy Department, Mater Hospital Brisbane, Raymond Terrace, South Brisbane QLD 4101
Country 137578 0
Australia
Phone 137578 0
+61 0403652991
Fax 137578 0
Email 137578 0
[email protected]
Contact person for public queries
Name 137579 0
Bronagh McAlinden
Address 137579 0
Physiotherapy Department, Mater Hospital Brisbane, Raymond Terrace, South Brisbane QLD 4101
Country 137579 0
Australia
Phone 137579 0
+61 0403652991
Fax 137579 0
Email 137579 0
[email protected]
Contact person for scientific queries
Name 137580 0
Bronagh McAlinden
Address 137580 0
Physiotherapy Department, Mater Hospital Brisbane, Raymond Terrace, South Brisbane, QLD 4101
Country 137580 0
Australia
Phone 137580 0
+61 0403652991
Fax 137580 0
Email 137580 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?
All de-identified data line by line
When will data be available (start and end dates)?
Immediately following publication and with no end date
Available to whom?
Researchers who provide a sound proposal
Available for what types of analyses?
IPD meta-analyses
How or where can data be obtained?
Contact PI Bronagh McAlinden through email: [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.