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Trial registered on ANZCTR

Registration number

ACTRN12623000903684

Ethics application status

Approved

Date submitted

7/08/2023

Date registered

23/08/2023

Date last updated

29/02/2024

Date data sharing statement initially provided

23/08/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Calculation Of Lung Inflation in Neonates

Scientific title

Validating the use of chest x-rays as measures of lung volume in neonates using computed tomography

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1296-3076

Trial acronym

COLIN Study

Linked study record

Not Applicible

Health condition

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

neonate

Respiratory Diseases

Mechanical Ventilation

Computerised Tomography

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This project aims to assess the relationship between the number of ribs seen on Chest Radiograph (CXR) and the lung volume and aeration measures on chest Computerised Tomography (CT) in ventilated neonates to evaluate the accuracy of using the CXR as a simple and convenient method of predicting lung volume and inflation in the clinical setting. CT images will be sourced from the Royal Children's Hospital (Melbourne) Medical Imaging Data based from 1 January 2011 to 1 September 2023.

Retrospective observational study of CT data of neonates <31 days of age (or <31 days corrected gestational age if born preterm) who meet study eligibility criteria. De-identified CT images will be segmented to calculate the left and right lung volume (cm3) and Hounsfeld Unit (aeration measure) value for each lung. The Scout CXR (Scout Topogram) will also be assessed using a standardised method to determine the rib number at the diaphragm of each lung. Absolute lung volume and aeration (Hounsfeld Unit value) will be compared to the rib level estimate of lung volume. Assessment of CT outcomes will be performed by at least 2 experienced independent assessors for each measure, who will be blinded to all assessor values. The same approach will be undertaken for CXR outcomes using a different team of assessors.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The distribution of total lung volume (ml/kg body weight) at each of the measured diaphragm positions in the study cohort (6-11 ribs).

Timepoint [1]

Time Computerised Tomography scan was performed

Secondary outcome [1]

The distribution of total lung volume (ml/kg body weight) at each of the measured diaphragm positions in the study cohort (6-11 ribs) during phase of respiratory cycle.

Timepoint [1]

Time Computerised Tomography scan was performed

Secondary outcome [2]

The distribution of total lung volume (ml/kg body weight) at each of the measured diaphragm positions in the study cohort (6-11 ribs) during of type of respiratory support.

Timepoint [2]

Time Computerised Tomography scan was performed

Secondary outcome [3]

The distribution of left lung volume (ml/kg body weight) at each of the measured left diaphragm positions in the study cohort (6-11 ribs).

Timepoint [3]

Time Computerised Tomography scan was performed

Secondary outcome [4]

The distribution of right lung volume (ml/kg body weight) at each of the measured right diaphragm positions in the study cohort (6-11 ribs).

Timepoint [4]

Time Computerised Tomography scan was performed

Secondary outcome [5]

The Hounsfield Unit values (measure of aeration state) at each of the measured diaphragm positions in the study cohort (6-11 ribs).

Timepoint [5]

Time Computerised Tomography scan was performed

Secondary outcome [6]

The Hounsfield Unit values (measure of aeration state) at each of the measured right diaphragm positions in the study cohort (6-11 ribs).

Timepoint [6]

Time Computerised Tomography scan was performed

Secondary outcome [7]

The Hounsfield Unit values (measure of aeration state) at each of the measured left diaphragm positions in the study cohort (6-11 ribs).

Timepoint [7]

Time Computerised Tomography scan was performed

Secondary outcome [8]

The Hounsfield Unit values (measure of aeration state) at each of the measured diaphragm positions in the study cohort (6-11 ribs) during phase of respiratory cycle. .

Timepoint [8]

Time Computerised Tomography scan was performed

Secondary outcome [9]

The Hounsfield Unit values (measure of aeration state) at each of the measured diaphragm positions in the study cohort (6-11 ribs) during of type of respiratory support.

Timepoint [9]

Time Computerised Tomography scan was performed

Eligibility

Key inclusion criteria

Neonates will be eligible if they have had a CT chest within the first 31 days of life (corrected gestational age) at the Royal Children’s Hospital in Melbourne, Victoria.

Minimum age

0 Days

Maximum age

30 Days

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Neonates will be excluded if they meet the following criteria:
1. The CT scan is conducted after 31 days corrected gestational age.
2. The scout CXR has a cardiothoracic ratio above 0.6 indicating cardiomegaly and distortion of the thoracic structures.
3. The scout CXR shows significant lordosis or scoliosis which would distort accurate assessment of rib/diaphragm relationship.
4. A single ventricle is identified on the CT scan.
5. Participants suffer from congenital lung pathology including congenital diaphragmatic hernia, congenital pulmonary airway malformation (previously congenital cystic adenomatoid malformations), pulmonary sequestration, congenital lobar emphysema, bronchogenic cysts.

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Defined population

Timing

Retrospective

Statistical methods / analysis

The aim is to analyse up to 300 CT scans from neonates who meet the study eligibility criteria. This number is based on preliminary discussions with the Department of Radiology as to the availability of scans stored within the Departments Database since the onset of the Royal Children’s Hospital current electronic medical record system (2011 to current). A feasibility sample size of at least 200 CT scans was determined to ensure a robust number subjects for each of the potential rib values (6-11) for reasonable interpretation after consultation with a Statistician at the Centre of Epidemiology and Biostatistics Unit (Murdoch Children's Research Institute).

The relationship between the diaphragm position and the calculated CT lung volume will be analysed and represented through a descriptive analysis and the distribution of lung volumes will be represented using boxplots. The relationship between CT measures and diaphragm position will be further assessed using correlation and linear regression analysis if appropriate. Subgroup analysis following the same methodology and stratification will be completed of the demographic data, HU, indication for CT, diagnosis and ventilation phase of the scans. Data analysis will be performed in the R Statistical Software package.

In the pilot work, an initial 30 randomly selected CT scans were assessed by three investigators twice using the CT volume calculation methods to assess reliability and reproducibility of volume calculations. The degree of discrepancy between the individual measurements will be determined by calculating the intra-class correlation coefficients with a two-way random effect model. Inter and intra-investigator was high (>95%).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

31/08/2023

Actual

4/09/2023

Date of last participant enrolment

Anticipated

30/11/2023

Actual

24/11/2023

Date of last data collection

Anticipated

16/01/2024

Actual

30/01/2024

Sample size

Target

258

Accrual to date

Final

218

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Murdoch Childrens Research institute Neonatal Research Group

Address [1]

Murdoch Childrens Research institute
50 Flemington Road
Parkville Victoria 3052

Country [1]

Australia

Primary sponsor type

Other

Name

Murdoch Childrens Research institute

Address

50 Flemington Road
Parkville Victoria 3052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Royal Childrens Hospital

Address [1]

50 Flemington Road
Parkville Victoria 3052

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

University of Melbourne

Address [2]

Department of Paediatrics
50 Flemington Road
Parkville Victoria 3052

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Children’s Hospital (Melbourne) Human Research Ethics Committee

Ethics committee address [1]

Department of Research Ethics and Governance
The Royal Children’s Hospital
50 Flemington Road
Parkville Victoria 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/06/2023

Approval date [1]

12/07/2023

Ethics approval number [1]

99967/RCHM-2023

Summary

Brief summary

Chest x-ray (CXR) are a simple and commonly used tool to assess the lungs of a neonate. Most neonates receiving assisted mechanical ventilation will have a CXR at some stage after starting treatment (many will have serial CXRs over time). Clinicians often use CXRs to help determine the impact of mechanical ventilation (use of a breathing machine to support diseased or sick lungs) on a patient’s lung.  It is commonly taught that lung volume can be assessed through the number of posterior ribs seen above the diaphragm in a CXR (diaphragm position; the more ribs the larger the lung volume). This is commonly used in adults to assess for emphysematous changes, or hyperinflation, in chronic obstructive lung disease or asthma. Counting ribs on a CXR, as a mechanism of quickly assessing lung, volume is often recommended in neonatal ICU guidelines. Normal inflation of the lung is considered to be between a diaphragm position of the 8-9th posterior rib, with less than 7 ribs indicating underinflated lungs and over 10 ribs indicating overinflated lungs, although varying thresholds are used. Estimation of lung volume using diaphragm position assessment is also commonly used to titrate specific ventilation settings. 

Despite being used to guide clinically important decisions, there have been few studies that have assessed and analysed the relationship between the number of ribs above the diaphragm and lung volume. Those that have assessed this question, have either found no significant relationship,2 or have formulated a 3D structure of the lungs from multiple scans to accurately represent lung volume, a method which is not used in clinical practice. There is a need to determine whether this common practice (counting ribs on CXR) to guide important intensive care interventions is useful as a measure of lung volume in neonates.

Computed Tomography (CT) is a gold standard measurement of lung aeration and volume.  It provides detailed information regarding the aeration of the lungs (such as the absolute amount of lung tissue collapsed or overdistended) and can provide the value and measurements of lung volume in ml/kg for an individual. However, due to the associated increased radiation exposure, CT is not routinely performed in neonates. 

The aim of this retrospective observational study is therefore to evaluate the relationship between the number of the ribs above the diaphragm on a CXR and the lung volume and aeration as measured through a CT chest. 

This study will be completed through a retrospective analysis of neonatal chest CTs from a data bank at the Royal Children’s Hospital in Melbourne, Victoria. Lung volume and aeration measures will be derived from CT imaging and compared to diaphragm position on the scout CT image (which is the same as a CXR) performed at the start of every CT. The relationship between lung volume, lung aeration and diaphragm position will then be compared.

Trial website

None

Trial related presentations / publications

Public notes

None

Contacts

Principal investigator

Name

Prof David Tingay

Address

Neonatal Research
Murdoch Childrens Research Institute
50 Flemington Road
Parkville Victoria 3052

Country

Australia

Phone

+61 03 93454023

Fax

Email

[email protected]

Contact person for public queries

Name

David Tingay

Address

Neonatal Research
Murdoch Childrens Research Institute
50 Flemington Road
Parkville Victoria 3052

Country

Australia

Phone

+61 03 93454023

Fax

Email

[email protected]

Contact person for scientific queries

Name

David Tingay

Address

Neonatal Research
Murdoch Childrens Research Institute
50 Flemington Road
Parkville Victoria 3052

Country

Australia

Phone

+61 03 93454023

Fax

Email

[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 of the individual participant data collected during the trial, after de-identification and primary publication

When will data be available (start and end dates)?

Beginning 3 months and ending 7 years following main results publication

Available to whom?

Researchers who provide a methodologically sound proposal, with approval by an independent review committee

Available for what types of analyses?

Any scientific purpose to achieve the aims in the approved proposal

How or where can data be obtained?

Access subject to approvals by Principal Investigator ([email protected]). Data requestors will need to sign a data access or material transfer agreement approved by Murdoch Childrens Research Institute.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
19938	Study protocol					386378-(Uploaded-07-08-2023-14-24-28)-Study-related document.pdf
19939	Data dictionary					386378-(Uploaded-07-08-2023-15-31-36)-Study-related document.pdf

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.