None listed
Conditions
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.
Interventions
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 (bil
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).
Sponsors
Perth Children's Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 18 Years
Healthy volunteers
No
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
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)
Outcome results
None listed