NIV mask and headgear evaluation
Research type
Research Study
Full title
PILOT EVALUATION OF 3D DESIGNED CUSTOM-MADE INTEGRATED MASK/HEADGEAR FOR CHILDREN USING NON-INVASIVE VENTILATION (The “COMFORT” Study – Customised Masks For Overnight Respiratory Therapy)
IRAS ID
334646
Contact name
Heather Elphick
Contact email
Sponsor organisation
Sheffield Children's Hospital
Duration of Study in the UK
0 years, 5 months, 28 days
Research summary
Non-invasive ventilation (NIV) is the delivery of breathing support via a facemask. It is used to treat people whose natural breathing is ineffective. Evidence shows that, when used long-term, it improves both quality of life and life expectancy.
Ventilation is delivered in the home through a mask covering the nose or the nose and mouth. A good fit between the mask and the patient’s face is essential to deliver the treatment effectively. Mass-produced masks are available for the adult market but in children it is often difficult to find a mask that provides an adequate fit. A particularly disadvantaged group is children with facial deformities or facial asymmetry. In these groups NIV may not be possible due to unavailability of an adequate mask.
Currently the options for these groups of children are to ventilate invasively via a breathing tube (tracheostomy) which can lead to serious complications and costly care-packages or to abandon ventilation, eventually leading to respiratory failure and premature death. Ersevering with an inadequately fitting mask leads to pressure sores, impairment of facial bone growth and significant disturbance to the sleep of the child and family due to noise from air leakage from the mask and alarms from the ventilator. These problems lead to an increased burden on nursing and hospital resources as well as harm and suffering to patients.
The COMFORT study was funded by the NIHR in 2015 to develop novel mask-face interfaces to optimise mask fit to the needs of individual patients using 3D assessment and manufacturing technologies. Since then, we have developed a mask prototype and a modular headgear prototype that straps the mask onto the face. We have already demonstrated that our proposed method is more effective than a standard mass-produced mask/headgear in the laboratory setting with adult volunteers.
In the first part of this project, we will carry out a proof-of-concept study to test the prototype mask/headgear system with children and young people that currently use NIV but have a poorly-fitting mask. We will compare our new system with their current mask by asking them to rate them in terms of comfort and fit as well as measuring the effectiveness of their ventilation. In the second part, we will work with Imperial University, who have developed software to automate and speed up the manufacturing process. We will scan 120 children to help develop the software to be suitable for children and then repeat the proof-of-concept study with a mask manufactured using the automated process. Following these studies we will apply for funding to carry out a multicentre UK-wide clinical trial.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
23/NW/0372
Date of REC Opinion
13 Dec 2023
REC opinion
Favourable Opinion