đź“Š Evidence-Based Reference
venturi mask adult paediatric
Dhd Medical Products Div. Diemolding
Summary: The Venturi Mask by Dhd Medical Products is a respiratory device used for precise oxygen delivery in adults and children. Key evidence highlights its role in managing hypoxemia and its safety profile.
FDA Clearance Information
Pathway
510K
Number
K860873 ↗
Decision Date
March 20, 1986
Product Code
BYF
Device Class
Class 1
Evidence
0 studies
The Venturi Mask was cleared by the FDA through the 510k pathway on March 20, 1986. Manufactured by Dhd Medical Products, it is classified as a Class 1 device.
What It Is
The Venturi Mask is a medical device designed to deliver a controlled concentration of oxygen to patients. It is commonly used in clinical settings to manage patients with respiratory distress by ensuring precise oxygen delivery.
Clinical Applications
The Venturi Mask is frequently used in scenarios requiring controlled oxygen therapy, such as in patients with chronic obstructive pulmonary disease (COPD) or during post-operative recovery to manage hypoxemia.
Evidence Summary
The available literature includes four studies ranging from 1981 to 2016, encompassing various study designs such as randomized controlled trials and case series. These studies explore oxygen delivery systems and their clinical outcomes.
Reported Outcomes
Published studies report that oxygen therapy can improve tissue oxygenation and potentially enhance clinical outcomes in patients with severe acute stroke and chronic lung disease. However, the effectiveness of different oxygen delivery systems, including the Venturi Mask, varies based on patient condition and clinical setting.
Safety Profile
Reported complications include potential risks of CO2 narcosis and apnea, particularly during sleep in patients with chronic lung disease. These findings highlight the importance of careful monitoring during oxygen therapy.
Evidence Limitations
The evidence is limited by the variability in study designs and patient populations. Further research is needed to establish standardized protocols and to evaluate long-term outcomes of Venturi Mask use in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for Venturi Mask?
The Venturi Mask is indicated for controlled oxygen delivery in patients with respiratory distress, such as those with COPD or post-operative hypoxemia.
What outcomes have been reported in clinical studies?
Studies report improved tissue oxygenation and potential clinical benefits in managing hypoxemia, though results can vary based on patient condition.
What complications have been reported?
Safety data indicate risks of CO2 narcosis and apnea, particularly in patients with chronic lung disease during sleep.
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.