Spirale® DDS - Drug Delivery System Setting the Scene Setting the scene • Inhaled bronchodilators reduce airway resistance, reduce the work of.
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Spirale® DDS - Drug Delivery System Setting the Scene Setting the scene • Inhaled bronchodilators reduce airway resistance, reduce the work of breathing and play a vital role in the care of patients with obstructive lung disease. • Immediate and effective bronchodilator therapy is pivotal to successful stabilization and weaning of mechanically ventilated patients. • It is not intuitively obvious to clinicians with ICU experience that many bronchodilator treatments given to intubated patients appear to have any clinical effect whatsoever. • This probably is often a result of very poor drug delivery to the lungs. – RESPIRATORY CARE • JULY 2010 VOL 55 NO 7 Optimal Particle Size • Particles with a mass of 1-5 μm are optimal for drug deposition. • Particles >5μm simply coat the Ventilator tubing and ET Tube. • 0.5 μm are too small for deposition and are exhaled again. • 2 - 5 μm are deposited inside the tracheobronchial airways. • 1- 2 μm are deposited in the alveolar. Optimal Particle Size Drug Delivery for the Mechanically Ventilated What are the Patient, Options? Nebulisers • • A nebuliser is a device used to administer medication in the form of a mist inhaled into the lungs . Three different types of nebulizers are used for aerosol drug delivery during mechanical ventilation. – Jet nebulizers – Ultrasonic wave nebulizers – Vibrating Mesh nebulizers Jet Nebulisers • Connected by tubing to a compressor that causes compressed air or oxygen to flow at high velocity through a liquid medicine to turn it into an aerosol. • Jet nebulisers create a particle mass of JN 2-5 μm. Jet Nebulisers Jet Nebulisers • Unit cost is relatively cheap but as they should be single use can be expensive practice. • Disconnection between use is an issue for loss of PEEP and VAP. • Large drug wastage with residual volume. • Time consuming. • Out put affected by flow rate. Ultrasonic Nebulisers • An electronic oscillator generates a high frequency ultrasonic wave using a piezoelectric crystal. This vibrating element is in contact with a liquid reservoir and its high frequency vibration is sufficient to produce a vapour mist. Ultrasonic Nebulisers • • • • • Capital equipment required. Drug wastage with residual volume. Noisy. Out put affected by medication volume, flow rate and position. Increase in temperature over time with risk of drug degradation. Vibrating Mesh Nebulisers • A mesh/membrane with 1000-7000 laser drilled holes vibrates at the top of the liquid reservoir, and thereby pressures out a mist of very fine droplets through the holes. • This technology has shorter treatment times, less liquid waste and undesired heating of the medical liquid. Vibrating Mesh Nebulisers Vibrating Mesh Nebulisers Vibrating Mesh Nebulisers • • • • • • • • • Particle size: 2.1µm MMAD. Consistent drug delivery. Does not heat or degrade medication. Inline. Heavy. Expensive. With ongoing maintenance , reprocessing or disposable costs. May require connectors. Still only 14% drug deposition. Although they have invested they may not always have enough machines available for every bed space. Nebulisers Summary • JNs are less efficient than ultrasonic and VM nebulizers. – (Harvey et al., 1993; Dhand, 2002,2004; Ari et al., 2009, 2010a; Waldrep and Dhand, 2008). • Although JNs are less expensive, both ultrasonic and VM nebulizers provide a higher rate of nebulization in a shorter period of time. – (Ari et al., 2010a; Dhand 2002, 2004; Harvey, 1993). Metered Dose Inhaler MDI cannister is depressed… …releasing a high velocity mixture of drugs and propellant. MDI in the hospital Identical Function • • • Different Adapter Adapter is inserted into the breathing circuit. MDI canister is inserted into adapter. Canister is depressed (in synchronization with patient inspiration). Performance of other MDI’s MDI with Chamber MDI with Chamber • MDI with Chamber (also commonly referred to as Spacer or Reservoir) – Large Particle mixture of drugs and propellant deposited within the chamber – As the mixture travels through the chamber the propellant evaporates and particle size decreases – Inhaled aerosol is enriched in small particles that travel deeper in the respiratory system and are absorbed by the lungs MDI with Chamber Particle Size How important is it??? A. Lung and oralpharyngeal deposition of large particle drug delivered through MDI B. Lung and oralpharyngeal deposition of small particle drug delivered through same MDI Particle Size is EVERYTHING! Leach CL, Davidson PJ, Boudreau RJ; Improved airway targeting with the CFC-free HFA-beclomethasone metered-dose inhaler compared with CFC-beclomethasone, Eur Respir J 1998 126 1346-1353 MDI with Chamber J L Rau, R J Harwood and J L Groff Chest 1992;102;924-930 MDI with Chamber (HOW IT WORKS) • MDI with Chamber The Chamber - How does it work? As time and distance travelled increases… •Smaller particles travel further into the lungs •Smaller particles are more easily absorbed by lung tissue. speed and particle size decrease. •The larger the chamber the smaller the particle Nebuliser Versus MDI Nebulizer vs MDI • • • • DRUG NEBULISER MDI Savings Salbutamol €0.13 €0.01 €0.12 Ipratropium €0.43 €0.02 €0.41 Combivent €0.54 €0.04 €0.50 – Prices are per single dose. – (British Medical Association & Royal Pharmaceutical Society of Great Britain, 2007) Nursing Time Savings • • It takes nurses 18 minutes to prepare, deliver, dismantle, wash and dry nebulisers. It takes one minute to administer MDI on patient with respiratory rate of 12/min. – (Salford Royal Hospitals NHS Trust, 2004) What the Papers Say • MDI & spacer = greater efficiency of aerosol deposition in lungs than nebulisers. – Fuller et al (1990) • MDI & spacer = most effective method of delivering inhaled bronchodilators in ventilated patients. – Marik et al (1999) What the Papers Say • “The use of a reservoir showed a significant increase in the amount of drug delivered.” • “Using a chamber spacer with the pMDI reduces losses in the circuit and increases drug delivery up to six fold.” – Ari et al. Factors Affecting Bronchodilator Delivery in Mechanically Ventilated Adults. 2010 British Association of Critical Care Nurses. Challenges for introduction • DRIVING FORCES Cost Effective RESTRAINING FORCES Staff Resistance Easy to Use Saline Nebs Cannot be delivered via MDI Reduced Risk of Infection Less Nursing Time Spent Little Evidence on MDI for Steroid Inhalation More Effective Dose Delivered Not required by all ventilator patients Less interference with Ventilation parameters Setting the scene Sales Strategy Implementation • • • • Multidisciplinary protocol Involve all groups Clinician, Nurse, Microbiology Pharmacy and Procurement • Present Strongly on… – – – – Drug Delivery Efficacy Infection Control, reduced risk Savings, Device, Drug and Time Customisation Areas for discussion Understand first your customers practice • Do we know how much drug we are giving the patient? What about residual volumes? • Breaking of the patient circuit with the obvious infection control issues….query storage of the patients nebulizer between treatments. Also consider loss of PEEP • Introducing cold fresh gas….upsetting volume settings….creating a delay period for patient tests e.g. blood gases. Why Spirale® • Spirale® DDS eliminates/reduces the need to break the circuit reducing the risk of VAP and other infections. • Spirale® DDS eliminates risk from environmental contamination. • Spirale® DDS can stay in the circuit for 7 days, requires no driving gas and therefore does not interfere with Ventilator settings. • Spirale® DDS provides accurate drug delivery. • Spirale® DDS allows for immediate blood gas analysis, assisting with early diagnosis and treatment of the patient. Why Spirale • Spirale® DDS reduces drug delivery costs. • Spirale® DDS saves nursing time – Ease of Use. • Spirale® DDS designed for use with the new generation of drug counter MDI’s. • Spirale® DDS reduces hospitals waste, less nebulizers thrown out. Setting the scene Features and Benefits Count the Doses… Only device on the market that accepts dose counter, allowing greater accuracy drug delivery Closed Circuit Internal locking mechanism seals to ensure a closed breathing circuit Easy to Use Self expanding when opened. Locks closed with a simple twist! Very Low Dead Space 16ml when collapsed Customized Solutions Available with a wide variety of catheter mounts, breathing circuits, HME filters, masks and other respiratory disposables from Armstrong Spirale® DDS - Drug Delivery System