ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000466640

Ethics application status

Approved

Date submitted

21/12/2021

Date registered

5/05/2023

Date last updated

5/10/2024

Date data sharing statement initially provided

5/05/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

3-Dimensional Printing Assisted Masks in Children with Obstructive and Restrictive Airway Disease

Scientific title

Safety and Tolerability of 3-Dimensional Printing Assisted Non Invasive Ventilation Masks in Children with Obstructive and Restrictive Airway Disease

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

airway obstruction

respiratory failure

non invasive ventilation

Condition category

Condition code

Respiratory

Sleep apnoea

Respiratory

Chronic obstructive pulmonary disease

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A digital image scanner will be used to create an accurate image of the patient's facial contour - This usually takes less than 5 minutes. This will then be made into a 3D printing assisted mask cushion made with medical grade silicone (ie the same material used for the standard NIV (non invasive ventilation) masks), fully customised to the contours of the patient’s face. These mask cushions are attached to a standard NIV mask and used with a CPAP (continuous positive airway pressure)/BiPAP (bilevel positive airway pressure) machine in place of a standard mask.

Assessment and monitoring of the effectiveness of NIV will occur exactly as per standard clinical care in the NIV initiation clinic. Patients are seen in the NIV clinic by a respiratory physician and nurse to fit the mask, determine appropriate NIV settings and the mask is fitted and NIV tested with the patient awake. The duration of the fitting and testing session usually takes 5-10 minutes.

The masks will be fitted as soon as they are available, as part of their routine clinical care with the respiratory team as for the conventional NIV masks. Their original off the shelf mask will be kept to be used as a backup. The parents and or mature minor will be sent reminders via email to complete the questionnaires according to the protocol. Patients will then wear the mask when sleeping. Patients will be asked to wear the mask for at least 2 weeks, and up to 12 months or longer (ie used as the replacement mask) if they tolerate it.

Adherence to intervention will be monitored via the questionnaires, as well as the data downloaded from their NIV machine (data will be recorded when the machine is used which is routine for all these machines).

Intervention code [1]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To assess the:
1) Preliminary safety (ie presence of pressures sores, skin reaction and effect on facial growth)
- This is assessed via the S3-NIV questionnaire is modified from Dupuis-Lozeron E et al which measures the fit and comfort of the mask, compared to the conventional masks.

Timepoint [1]

These questionnaires will be repeated at 2 weeks, 1-, 3-, 6- and 12-month post mask fitting.

Primary outcome [2]

2) Tolerability (ie fit and comfort) of the customised 3D printed NIV masks compared to the conventional masks.
- This is subjectively measured via these questionnaires: The OSA (obstructive sleep apnea)-18 Quality of Life Survey which measures the child’s quality of life, and Paediatric Sleep Questionnaire which measures the impact of the respiratory failure
- This is objectively measured via data that is downloaded from their NIV machine regarding:
a) Usage days (=4 hours and <4 hours; a measure of compliance)
b) Average usage hours (a measure of compliance)
c) Median pressure (cmH20; the pressure of air needed to overcome their lung disease)
d) Median leaks (L/min; the amount of air leak)
e) Apnoea Hypopnoea Index (AHI; the degree of obstruction with the mask)

Timepoint [2]

These questionnaires will be repeated at 2 weeks, 1-, 3-, 6- and 12-month post mask fitting.

Secondary outcome [1]

1) To evaluate the preliminary performance:
- Changes in compliance assessed with study-specific questionnaire
- Average AHI (Apnea hypopnea index) assessed via data linkage to NIV machine
compared with their previous use of conventional masks

Timepoint [1]

All the questionnaires and NIV downloaded data will be repeated at baseline, 2 weeks, 1-, 3-, 6- and 12-month post mask fitting.

Secondary outcome [2]

2) To evaluate the preliminary performance:
- Average AHI (Apnea hypopnea index) assessed via data linkage to NIV machine
compared with their previous use of conventional masks

Timepoint [2]

All the questionnaires and NIV downloaded data will be repeated at baseline, 2 weeks, 1-, 3-, 6- and 12-month post mask fitting.

Secondary outcome [3]

3) To evaluate the feasibility of the study based on recruitment rate, retention rate and the ability of patients to complete the questionnaires.

Timepoint [3]

This is assessed at the end of the study via audit of the study records:
- Recruitment rate: Total number of patients recruited over the study period
- Retention rate: The number of patients that stayed in the study over the study period
- Ability of patients to complete the questionnaires: The number of completed questionnaires at baseline, 2 weeks, 1-, 3-, 6- and 12-month post mask fitting.

Eligibility

Key inclusion criteria

1) Inability to tolerate conventional masks due to: Fit, leak, hypoxemia, and pressure sores.
2) Ongoing need for NIV masks based on respiratory physician assessment, qualitatively based on the comfort, leak, pressure areas, as well as quantitative data from the NIV machine regarding the compliance and AHI. A formal polysomnography may be requested if further quantification of the need for NIV is required.
3) Respiratory physician assessment to ensure that non-compliance is due to inability to tolerate NIV masks secondary to poor fit, measured via the Mask Fit & Comfort questionnaire, and the objective downloadable data where they are non compliant with its use.
4) Exhausted the 2 commercially available mask options at Perth Children’s Hospital.
5) Consent from caregivers and or mature minors

Minimum age

0 Years

Maximum age

18 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1) Patients over the age of 18 years old
2) Patients not needing NIV masks
3) Patients for whom commercially available NIV masks fit well
4) Allergic skin reaction to commercially available NIV masks (medical grade silicone)

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

Safety/efficacy

Statistical methods / analysis

Descriptive analysis is the main statistical method due to the small number anticipated. Continuous data will be reported as means and standard deviations or medians and interquartile ranges if the distribution is skewed. Categorical data will be reported as frequencies and percentages. QoL outcomes will be plotted using a line graph (outcome measure over time) for each individual looking for trends.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

3/02/2025

Actual

Date of last participant enrolment

Anticipated

31/12/2029

Actual

Date of last data collection

Anticipated

2/05/2030

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Perth Children's Hospital

Address [1]

15 Hospital Ave, Nedlands WA 6009

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

East Metropolitan Health Service

Address [2]

10 Murray St, Perth WA 6000

Country [2]

Australia

Primary sponsor type

Hospital

Name

Perth Children's Hospital

Address

15 Hospital Ave, Nedlands WA 6009

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

East Metropolitan Health Service

Address [1]

10 Murray St, Perth WA 6000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Child and Adolescent Health Services Ethics Comittee

Ethics committee address [1]

15 Hospital Ave, Nedlands WA 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/05/2021

Approval date [1]

27/10/2021

Ethics approval number [1]

RGS0253

Summary

Brief summary

Non-invasive ventilation (NIV) is a medical treatment that delivers pressurised air to the airways, reducing the effort of breathing and improving gas exchange. It is most commonly used in children to treat airway obstruction and respiratory failure. As everyone has a unique facial structure, a one-size-fits-all conventional NIV mask is not suitable for all children, especially those with cranio-facial abnormalities or; different facial sizes, structures and growths. Children often stop wearing their masks due to discomfort, making treatment in these patients challenging.

We aim to demonstrate that personalised mask is as safe as the conventional mask, will be more comfortable, resulting in improved compliance, and therefore clinical outcome.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jennifer Ha

Address

Perth Children's Hospital
15 Hospital Ave, Nedlands WA 6009

Country

Australia

Phone

+61 8 64562222

Fax

[email protected]

Contact person for public queries

Name

Jennifer Ha

Address

Perth Children's Hospital
15 Hospital Ave, Nedlands WA 6009

Country

Australia

Phone

+61 8 64562222

Fax

[email protected]

Contact person for scientific queries

Name

Jennifer Ha

Address

Perth Children's Hospital
15 Hospital Ave, Nedlands WA 6009

Country

Australia

Phone

+61 8 64562222

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

To protect anonymity of patients

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14493	Ethical approval					383324-(Uploaded-21-12-2021-05-58-31)-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.

Trial Review

Documents added manually

Documents added automatically