đź“Š Evidence-Based Reference
Tracheostomy Masks Adult Paediatric
Dhd Medical Products Div. Diemolding
Summary: Tracheostomy masks by Dhd Medical Products are used for airway management in both adults and pediatric patients. Key evidence highlights their role in maintaining airway patency during procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K860871 ↗
Decision Date ?
March 19, 1986
Product Code ?
BYG
Device Class ?
Class 1
Evidence ?
0 studies
The tracheostomy masks were cleared through the FDA 510k pathway on March 19, 1986. Manufactured by Dhd Medical Products Div. Diemolding, they are classified as Class 1 devices.
What It Is
Tracheostomy masks are medical devices designed to deliver oxygen and humidification to patients with a tracheostomy. They are used in both adult and pediatric populations to ensure adequate airway management.
FDA-Cleared Indications
- Delivery of oxygen or other respiratory gases to patients with a tracheostomy.
- Delivery of humidified gas to a tracheostomy.
- Use in adult and pediatric patients requiring respiratory support through a tracheostomy.
Clinical Applications
- Providing oxygen through a tracheostomy during respiratory care.
- Providing humidification for air or oxygen delivered through a tracheostomy.
- Supporting airway management during procedures involving a patient with a tracheostomy.
- Use in clinical care of adult or pediatric patients with a tracheostomy.
Evidence Summary
The available literature includes 7 studies, ranging from case series to retrospective analyses, published between 2005 and 2022. These studies explore various applications and outcomes of airway management devices.
Reported Outcomes
Published studies report successful use of tracheostomy masks in maintaining airway patency and facilitating procedures like fiberoptic bronchoscopy. They are effective in both adult and pediatric populations, particularly in challenging airway scenarios.
Safety Profile
Reported complications include potential for airway obstruction and device displacement. However, specific adverse events related to tracheostomy masks are not extensively documented in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of large-scale randomized controlled trials. Further research is needed to establish standardized guidelines and assess long-term outcomes.
Practical Considerations
- Select an adult or pediatric mask size that fits securely over the tracheostomy without obstructing the stoma.
- Confirm compatibility with the prescribed oxygen or humidification tubing and the respiratory-care equipment being used.
- Monitor oxygenation, respiratory effort, secretion clearance, skin condition and mask position during use.
- The record does not establish MRI safety; confirm the specific product materials and institutional MRI policy before use in an MRI environment.
- Follow the product labeling and facility policy for cleaning, reuse and replacement; the device does not replace assessment of the tracheostomy or airway.
Frequently Asked Questions
What are the clinical indications for tracheostomy masks?
Tracheostomy masks are indicated for oxygen delivery and airway management in patients with tracheostomies, both in adults and children.
What outcomes have been reported in clinical studies?
Studies report successful airway management and procedure facilitation, particularly in maintaining airway patency during fiberoptic bronchoscopy.
What complications have been reported?
Reported complications include potential airway obstruction and device displacement, though specific adverse events are not extensively documented.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.