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

Not Applicable

• Conditions: airway obstruction; respiratory failure; non invasive ventilation; Respiratory - Sleep apnoea; Respiratory - Chronic obstructive pulmonary disease; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12623000466640
• Lead Sponsor: Perth Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-05
• Last Update Posted: 15 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified