Training. Freiburg
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1 Training Freiburg
2 AGENDA 1. Background & Methodology 2. USP s 3. Use Cases
3 AGENDA 1. Background & Methodology 2. USP s 3. Use Cases
4 CLINICAL INDICATION Patient having problems breathing through the nose Allergic reactions on the mucosa (allergen, medication) Hypertrophic turbinates Septal deviation (before and after surgery) Nasal valve collapse Nasal polyps
5 WHY NASAL AIRWAY FUNCTION TESTS? Common Diagnosis Medical history, questionnaire Inspection (anterior rhinoscopy) Function tests: WHY? Can you estimate the relation between form and function? NO Hagen-Pouseuille law: resistance R= 8ηl πr 4 r=1 r=0,5: half radius, 16-times resistance! RH 7011 V
6 WHAT KIND OF NASAL AIRWAY FUNCTION TEST? Peak Nasal Inspiratory Flow (PNIF) quick assessment of the patency of the nose Rhinomanometry (AAR, APR, Rhinoresistometry, 4PR) Measurement of difference pressure between anterior and posterior opening of nasal cavity and nasal airflow Nasals airway resistance (quotient) Acoustic Rhinometry Measurement of reflected ultrasonic waves (MCA) Morphological changes in nasal airway
7 WHAT KIND OF NASAL AIRWAY FUNCTION TEST? CFD (Computational Fluid Dynamics) Nasal Airway Model 3D-model based on CT images Simulation & visualization of nasal airflow Future: 4PR combined with CFD better understanding of interaction between morphology & function Improvement of diagnostic and treatment
8 HISTORY OF CLASSIC RHINOMANOMETRY 1960: COTTLE and MASING introduce Rhinomanometry : Development of digital Rhinomanometry Mayo-Clinic Rochester MA (KERN, PALLANCH) Charité Berlin (VOGT, WERNECKE, SACHSE, HOFFRICHTER) 1990: Worldwide first commerical Rhinomanometer CARIMA at the Charité 1983: ISCOANA is established as institution of Int. Rhinologic Society 1984: ISOCANA defines first standard in Rhinomanometry 1997: Rhinolab founded by Prof. Dr. Dr. VOGT 2012: Acquisition by Sutter Medizintechnik 2015: Introduction of 4Rhino in Europe and Chinese market RH 7011 V
9 LIMITATION OF CLASSIC RHINOMANOMETRY (since 1984!) One-Point measurement in a phase of non-linear breathing (acceleration, deceleration) 150 Pa frequently not reachable not representing the entire breathing cycle Low correlation with feeling of nasal obstruction 150 PA Need for improvement as motivation for development of 4PR State-of-the-art sensor technology and information technology averaging bylinear regression Need for Update of Standard & Quality requirements for medical device 2003: Consensus Conference (Brüssel); Consensus Report, Rhinology : Consensus Conference (Riga); Riga Agreement, Rhinology 2018
10 4-PHASE RHINOMANOMETRY ~ individual measurements (highly accurate digital sensors) sophisticated signal processing (ampification and averaging) high resolution rhinomanometry new xt-graph: visualization of breathing cycle xy-graph: 4 phases of one cycle get depicted facilitates introduction of new but established parameters
11 VERTEX RESISTANCE (VR) new resistance at point of max. flow during NORMAL breathing during steady phase where no acceleration occurs VR
12 EFFECTIVE RESISTANCE (Reff) new established parameter in electrical engineering = energy time gets an essential diagnostic factor evaluates the work of breathing throughout the entire breath Root Square Mean (RSM): Square root of integral of measured values
13 WEBER-FECHNER LAW: LOGARITHMIC PERCEPTION relates to human perception: subjective sensation is proportional to the logarithm of the stimulus intensity Logarithmic perception is valid for all stimuli to all senses vision, hearing, taste, touch, and smell also valid for breathing effort Logarithmic transformation: log Reff and log VR Distributions of histograms approach a normal distribution Higher correlation with subjective values for obstruction (pre-study of n=1.580)
14 CLASSIFICATION OF TOTAL NASAL OBSTRUCTION new Based on normal distribution of histogram log Reff and log VR Classification System was introduced (20% percentiles) validated with > cases Quick assessment of nasal obstruction Histogram of Log Reffin
15 LOG EFFECTIVE RESISTANCE new Consensus Conference 2016 (Riga): Log Reff was set as parameter of high diagnostic relevance 1 Rhinology 56: 0-0, 2018, Open Access 1 Vogt K et al., The Riga agreement of the international consensus conference on nasal airway function tests, Rhinology 56: 0-0, 2018, Open Access
16 VISUALIZATION OF THE NASAL VALVE PHENOMENON new Nasal valve: a dynamic functional structure flow narrows the air channel during measurement process (Bernoulli effect) Valve closure forced by inspiratory airflow Intended: Sniffing Instinctive: Shock-absorber to limit volume of unconditioned air Valve closure premature onset caused by weak cartilage, or skin forming the nasal entrance Example: During acceleration the flow follows the pressure up to 600 Pa Pressure Flow Valve closure, pressure continues to increase but flow decreases
17 HOW TO MEASURE IN RHINOMANOMETRY? Nasal Entry AAR, 4PR APR
18 HOW TO CLOSE THE NASAL ENTRY BEST? Foam olive adapter Elastic tape
19 4RHINO: REPRESENTATION OF GRAPHS AND RESULTS Diagnosis on the first view Numeric evaluation Degree of obstruction of each side of the nose or the total nose Influence of the nasal valve Decongestion test Nasal provocation test Supported OS
20 AGENDA 1. Background & Methodology 2. USP s 3. Use Cases
21 USP s Realistic visualization of breathing cycle Immediate representation of nasal valve phenomenon Best possible correlation between objective measurement and subjective sensation Quick Classification of Obstruction (validated > cases)
22 SINGLE-USE MASK Avoid Cross-Contamination Time & Cost Saving User friendly
23 AGENDA 1. Background & Methodology 2. USP s 3. Use Cases
24 NORMAL NOSE: DECONGESTION TEST Pattern Curves clearly vertical Only slight difference after decongestion Red curve: right side of nose Blue curve: left side of nose Black curves: after decongestion
25 TEMPORARY OBSTRUCTION Pattern Curves are more horizontal Remarkable distance between measurement before and after decongestion Before decongestion After decongestion Diagnosis Common Cold Hyperreactivity Allergy Rhinitis medicamentosa Sinusitis Polyps
26 PERMANENT OBSTRUCTION Pattern Curves clearly horizontal One sided (patient 1) Both sides (patient 2) Only slight difference after decongestion Diagnosis Septal deviation Stenosis Malformations Septal deviation left Nasal valve phenomenon left Post traumatic septum deviation on both sides. No mucosal reaction
27 PRONOUNCED NASAL CYCLE Pattern Before decongestion the patency of right and left differ at two different days After decongestion both sides have the same patency at both days green: day 1 black: day 2 green: day 1 black: day 2 Before decongestion After decongestion RH 7011 V
28 NASAL VALVE PHENOMENON Pattern Remarkable distance between phase 1 and phase 2 (inspiration) loop low - moderate heavy
29 EFFECTIVNESS CONTROL OF THERAPY Example: Turbinate reduction with radiofrequency (RaVoR TM ) preop. postop.
30 AGENDA 1. Background & Methodology 2. USP s & Competitors 3. Use Cases
31 AGENDA 1. Background & Methodology 2. USP s & Competitors 3. Use Cases
32 Contact: Dr. Simone Peschl Phone: Fax: Web: Rhinolab GmbH Tullastraße Freiburg Freiburg
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