ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Preterm birth

Lung collapse and consolidation

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Reproductive Health and Childbirth

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]

Treatment: Other

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in lung collapse on Lung Ultrasound (LUS)

Timepoint [1]

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]

Change in auscultation score

Timepoint [1]

Auscultation, and auscultation scores, will be collected immediately prior to CPT, immediately after CPT and again at 4 hours post CPT.

Secondary outcome [2]

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]

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]

Changes in set Tidal volume or Inspiratory pressure (depending on whether infant is ventilated on a volume mode or a pressure mode)

Timepoint [3]

Tidal volume/ set inspiratory pressure be collected immediately prior to CPT, immediately after, and at 4 hours post CPT

Secondary outcome [4]

Changes in Fraction of inspired oxygen (FiO2)

Timepoint [4]

FiO2 will be recorded immediately prior to CPT, immediately after CPT and at 4 hours after the completion of CPT

Secondary outcome [5]

Changes in oxygen saturations (SpO2)

Timepoint [5]

SpO2 will be recorded immediately prior to CPT, immediately after CPT and at 4 hours after the completion of CPT

Secondary outcome [6]

Changes in transcutaneous carbon dioxide level (TCO2) where available (if being used with infant at the time of CPT)

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Mater Research

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Bronagh McAlinden - Mater Hospital Brisbane

Address

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Judith Hough - Mater Hospital Brisbane

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Mater Misericordiae Ltd Human Research Ethics Committee

Ethics committee address [1]

http://www.materresearch.org.au/about-us/human-research-ethics-and-governance/human-research-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/10/2024

Approval date [1]

Ethics approval number [1]

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

Ms Bronagh McAlinden

Address

Physiotherapy Department, Mater Hospital Brisbane, Raymond Terrace, South Brisbane QLD 4101

Country

Australia

Phone

+61 0403652991

Fax

bronagh.mcalinden@health.qld.gov.au

Contact person for public queries

Name

Bronagh McAlinden

Address

Physiotherapy Department, Mater Hospital Brisbane, Raymond Terrace, South Brisbane QLD 4101

Country

Australia

Phone

+61 0403652991

Fax

bronagh.mcalinden@health.qld.gov.au

Contact person for scientific queries

Name

Bronagh McAlinden

Address

Physiotherapy Department, Mater Hospital Brisbane, Raymond Terrace, South Brisbane, QLD 4101

Country

Australia

Phone

+61 0403652991

Fax

bronagh.mcalinden@health.qld.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?

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: bronagh.mcalinden@mater.org.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.

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