Assessment of a Ventilator Circuit Adapter to be Used in Conjunction with the Respimat † Soft Mist Inhaler RATIONALE • W ith the introduction of the Respimat † Soft Mist Inhaler (SMI) there is a desire for an adapter to allow its use in ventilator circuits. An adapter (RespiConnect* Adapter) was assessed in terms of drug delivery and safety features. • Patients on mechanical ventilation either involving prophylactic delivery of bronchodilators, or receiving such medication to treat a severe COPD exacerbation may need continuous therapy Excellence By Design J. Suggett, M. Nagel Trudell Medical International, London, Canada. MD-800A-0717. * trade-marks and registered trade-marks of Trudell Medical International. † trade-marks and registered trade-marks of Boehringer Ingelheim. Copyright © Trudell Medical International 2017. ERS International Congress Milan, Italy September 9 – 13, 2017 METHODS • Each adapter (n=10) was inserted in the inspiratory limb of a heated adult ventilator circuit • A 7.0 mm Endotracheal Tube (ET) was attached to a filter and the distal side of the filter coupled to an adult test lung to simulate a patient • A Servo ventilator (SV900C, Siemens, Sweden) delivered the required breathing pattern: • T idal volume (V t ) = 600 mL • 10 breaths/minute • Inspiratory/expiratory (I/E) ratio = 1:3 • 5 cm H 2 O Positive End Expiratory Pressure (PEEP) RESULTS • During the experiment the circuit did not lose pressure and no alarms were triggered, indicating that the self sealing valve was effective • Mean values of 30.3% and 29.4% LC were determined for SAL and IPR respectively CONCLUSIONS • It is known that not having a good consistent seal can jeopardize the safety of the patient through circuit leakages and a consistent seal is also needed in order to achieve adequate drug delivery to the patient • The presence of a self-sealing valve and safety cap for the RespiConnect* Adapter should ensure ventilator circuit integrity and therefore also help protect the safety of the patient • Approximately 30% LC of both drug components in the SMI was delivered to the distal end of ET tube via the adapter • This study provides clinicians assurance regarding circuit integrity and likely drug delivery performance when using the RespiConnect* Adapter • A ventilator circuit humidifier (model MR50JHU, Fischer- Paykel, Auckland, NZ) was used to maintain conditions close to body temperature and saturation with water vapour • Five actuations of Combivent † SMI were delivered, each actuation followed by 6 complete breathing cycles • Between actuations the SMI was removed from the adapter and primed according to manufacturer’s instructions • Salbutamol (SAL) and Ipratropium (IPR) were recovered from the filter and quantified by HPLC as % Label Claim (LC) STUDY PURPOSE • The RespiConnect* Adapter was designed for safety and mechanical performance • The self-sealing mechanical valve maintains the integrity of the ventilator circuit at all times; a redundant cap is incorporated for extra safety • This study assessed mechanical performance through its ability to retain circuit integrity as well as aerosol drug delivery in a ventilator RespiConnect* Adapter Trudell Medical International London, Canada RespiConnect* Adapter with Respimat † SMI Experimental Lab Set-up Flow pattern of RespiConnect* Adapter with RespiConnect † SMI engaged • Aerosol delivery was optimized through CFD analysis during adapter design Servo ventilator Inhalation (humidified air) Respimat † SMI RespConnect* Adapter Wye connector ET Filter Adult test lung Circuit humidifier Exhalation Drug In Air + Drug Out Air Out

Assessment of a Ventilator Circuit Adapter to be Used in … · 2020-04-06 · Assessment of a Ventilator Circuit Adapter to be Used in Conjunction with the Respimat † Soft Mist

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Page 1: Assessment of a Ventilator Circuit Adapter to be Used in … · 2020-04-06 · Assessment of a Ventilator Circuit Adapter to be Used in Conjunction with the Respimat † Soft Mist

Assessment of a Ventilator Circuit Adapter to be Used in Conjunction with the Respimat† Soft Mist Inhaler

RAtIonAle•WiththeintroductionoftheRespimat†SoftMistInhaler(SMI)thereisadesireforanadaptertoallowitsuseinventilatorcircuits.Anadapter(RespiConnect*Adapter)wasassessedintermsofdrugdeliveryandsafetyfeatures.

•Patientsonmechanicalventilationeitherinvolvingprophylacticdeliveryofbronchodilators,orreceivingsuchmedicationtotreatasevereCOPDexacerbationmayneedcontinuoustherapy

Excellence By Design

J. Suggett, M. NagelTrudellMedicalInternational,London,Canada.

ERS International Congress Milan, Italy

September 9 – 13, 2017

MethodS•Eachadapter(n=10)wasinsertedintheinspiratorylimbofaheatedadultventilatorcircuit

•A7.0mmEndotrachealTube(ET)wasattachedtoafilterandthedistalsideofthefiltercoupledtoanadulttestlungtosimulateapatient

•AServoventilator(SV900C,Siemens,Sweden)deliveredtherequiredbreathingpattern:

•tidalvolume(Vt)=600mL

•10breaths/minute

•Inspiratory/expiratory(I/E)ratio=1:3

•5cmH2OPositiveEndExpiratoryPressure(PEEP)

ReSUltS•Duringtheexperimentthecircuitdidnotlosepressureandnoalarmsweretriggered,indicatingthattheselfsealingvalvewaseffective

•Meanvaluesof30.3%and29.4%LCweredeterminedforSALandIPRrespectively

ConClUSIonS•Itisknownthatnothavingagoodconsistentsealcanjeopardizethesafetyofthepatientthroughcircuitleakagesandaconsistentsealisalsoneededinordertoachieveadequatedrugdeliverytothepatient

•thepresenceofaself-sealingvalveandsafetycapfortheRespiConnect*Adaptershouldensureventilatorcircuitintegrityandthereforealsohelpprotectthesafetyofthepatient

•Approximately30%LCofbothdrugcomponentsintheSMIwasdeliveredtothedistalendofETtubeviatheadapter

•thisstudyprovidescliniciansassuranceregardingcircuitintegrityandlikelydrugdeliveryperformancewhenusingtheRespiConnect*Adapter

•Aventilatorcircuithumidifier(modelMR50JHU,Fischer-Paykel,Auckland,NZ)wasusedtomaintainconditionsclosetobodytemperatureandsaturationwithwatervapour

•FiveactuationsofCombivent†SMIweredelivered,eachactuationfollowedby6completebreathingcycles

•BetweenactuationstheSMIwasremovedfromtheadapterandprimedaccordingtomanufacturer’sinstructions

•Salbutamol(SAL)andIpratropium(IPR)wererecoveredfromthefilterandquantifiedbyHPLCas%LabelClaim(LC)

StUdY PURPoSe•theRespiConnect*Adapterwasdesignedforsafetyandmechanicalperformance

•theself-sealingmechanicalvalvemaintainstheintegrityoftheventilatorcircuitatalltimes;aredundantcapisincorporatedforextrasafety

•thisstudyassessedmechanicalperformancethroughitsabilitytoretaincircuitintegrityaswellasaerosoldrugdeliveryinaventilator

RespiConnect*AdapterTrudell Medical International London, Canada

RespiConnect*AdapterwithRespimat†SMI

Experimental Lab Set-up