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 μm are deposited inside the tracheobronchial airways μm are deposited in the alveolar.

Optimal Particle Size

Drug Delivery for the Mechanically Ventilated Patient, What are the 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

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 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

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).

…releasing a high velocity mixture of drugs and propellant. MDI cannister is depressed… Metered Dose Inhaler

MDI in the hospital Adapter is inserted into the breathing circuit. MDI canister is inserted into adapter. Canister is depressed (in synchronization with patient inspiration). Identical Function Different Adapter

Performance of other MDI’s

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??? 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 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!

MDI with Chamber J L Rau, R J Harwood and J L GroffChest 1992;102;

MDI with Chamber The Chamber - How does it work? As time and distance travelled increases… speed and particle size decrease. The larger the chamber the smaller the particle Smaller particles travel further into the lungs Smaller particles are more easily absorbed by lung tissue. MDI with Chamber (HOW IT WORKS)

Nebuliser Versus MDI

Nebulizer vs MDI DRUGSalbutamol Ipratropium Combivent NEBULISER€0.13 €0.43€0.54 MDI€0.01 €0.02 €0.04 Savings €0.12 €0.41 €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 “When MDIs are used with a collapsible cylindrical spacer it is not necessary to disconnect the ventilator circuit for each treatment, thereby reducing the risk of Ventilator-Associated Pneumonia.” “Both in vitro and in vivo studies have found that the combination of an MDI and a chamber device results in a four to six fold greater delivery of aerosol than MDI actuation into a connector attached directly to the endotracheal tube or into an in- line device that lacks a chamber.” – Dhand R et al. Inhaled Bronchodilator Therapy in Mechanically Ventilated Patients. American Journal of Respiratory and Critical Care Medicine. Vol 156, 1997

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 British Association of Critical Care Nurses.

What the papers say “The most important factors influencing drug delivery are use of humidification, synchronisation with inspiration, a delay between doses and use of a spacer.” “Using a spacer is key to success in both ambulatory and ventilated patients. It is fundamental in improving the efficacy of bronchodilator therapy given by MDI.” – J Scally et al. Delivery of Inhaled Beta Agonists by Metered-Dose Inhaler in Ventilated Patients. JICS (Journal of Intensive Care Society) Vol 11, No 1 Jan 2010.

Other Opportunities? Airway Emergency Airway emegency during anaesthesia using a metered-dose inhaler Attachment: anaesthesia figures 1 & 2.JPGanaesthesia figures 1 & 2.JPG I read with interest the letter [1] relating to the accidental fragmentation into the patient’s bronchus of the tip of a Luer lock syringe connected to the proximal end of a patient’s artificial airway for administering salbutamol via a metered dose inhaler in the barrel of the 50-ml syringe. However I disagree with the authors when they state that no proprietary adapter exists for the administration of a bronchodilator via a metered dose inhaler in such situations. We have successfully used a drug delivery system (Spirale® DDS, Armstrong Medical Ltd., Coleraine, Northern Ireland) for administration of salbutamol via a metered dose inhaler to anaesthetised patients on many occasions at our institution. In the closed position, the Spirale® DDS adapter is connected to the proximal end of the artificial airway adding minimal deadspace (Fig. 1). When the adapter is opened (Fig. 2), the metered dose inhaler can be attached to the actuator port and the drug delivered to create a mist in the ‘voluminising chamber’ that ensures a greater percentage of drug is delivered to the bronchi. The Spirale® DDS can be used for patients under anaesthesia as well as in the intensive care unit for both spontaneously breathing and ventilated patients. No external funding and no competing interests declared. A. Kusurkar Lagan Valley Hospital Lisburn, UK Reference 1 Featherstone P, Abdelaal A, Duane D. Airway emergency during anaesthesia using metered dose inhaler. Anaesthesia 2011; 66:58. Figure legends Figure 1 Spirale® DDS adapter in closed position attached to proximal end of tracheal tube Figure 2 Spirale® DDS adapter in open position with metered dose inhaler attached to actuator port

Challenges for introduction DRIVING FORCES RESTRAINING FORCES Cost Effective 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.

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 Very Low Dead Space 16ml when collapsed Easy to Use Self expanding when opened. Locks closed with a simple twist! Customized Solutions Available with a wide variety of catheter mounts, breathing circuits, HME filters, masks and other respiratory disposables from Armstrong Setting the scene

Spirale® DDS - Drug Delivery System