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TNI ® Studies 46 Therapy Diagnostics 196 AMERICANJOURNALOFRESPIRATORYANDCRITICALCAREMEDICINE VOL 176 2007 of interrater variability was performed by two board-certified sleep physiciansinasubsetofsubjects(n �9). Breathingdynamics. End-expiratorypharyngealpressure,peakinspiratoryairflow,andrespiratoryeffortweremeasuredonthebasisof the10breathsimmediatelyprecedingandthelast10breathsofeach TNItrial. Statistical Analysis Dataarereportedasmeans �SEM.Asignranktestwasperformed (Stata 8;StataCorp,CollegeStation,TX) tocompare (1)differences inpolysomnographic indices betweenbaselinediagnostic andclinical treatmentnightand(2)differencesinbreathingdynamicsonandoff TNI.pValueslessthan0.05wereconsideredsignificant. RESULTS Subject Demographics Elevensubjects(6menand5women;age,49.7 �5.0yr;body massindex,30.5 �4.3kg/m 2 )completedthestudy.Bydesign, ourstudypopulationencompassedawidespectrumfrommildto severediseaseseverity(Table1).Ingeneral,patientswithmilder diseaseseverityhadpredominantlyobstructivehypopneas(AHI, 5–15events/h),whereasthosewithmoreseveresleepapnea(AHI, �30events/h)hadmanymoreobstructiveapneas. TNI Titration at 10 versus 20 L/Minute: Night 1 Figure2illustratestheeffectofTNIat10and20L/minuteon airflowdynamicsandsupraglotticpressureinonesubjectwith predominantly obstructive hypopnea (subject 1, indicated by opencirclesinFigure4).BreathsoffTNI(Figure2,left)during a hypopnea were characterized by a plateauing of inspiratory flowassupraglotticpressurecontinuedtofall,andsnoring(microphone signal). A TNI flow rate of 10 L/minute (Figure 2, middle) slightly increasedend-expiratory supraglottic pressure and decreased inspiratory effort swings. Nevertheless, inspiratoryflow limitationandsnoringpersisted.Incontrast,breaths on TNI at 20 L/minute (Figure 2, right) were no longer flow limitedasindicatedbyaroundedinspiratoryflowcontour,an increaseinpeakinspiratoryairflow,amarkeddeclineinsupraglotticpressureswings,andtheabsenceofsnoring.Similarresultswerefoundinallourstudyparticipants. Effect on Sleep-disordered Breathing Indices In Figure 3, the effect of TNI at 20 L/minute on the sleepdisorderedbreathingpatternisillustratedforonesubjectwith obstructive hypopneas. Figure 3 (left) depicts two obstructive hypopneas(seehorizontalbars)asindicatedbydecreasedinspiratoryairflow,progressivelyincreasingrespiratoryeffort(Psg), snoring(seemicrophonetrace),andoxygendesaturations.When TNI was administered (Figure 3, right), sleep and breathing patternsstabilized,asreflectedbythereductioninsupraglottic pressure swings, and resolution of inspiratory flow limitation, snoring,andoxyhemoglobindesaturation. InFigure4,thesleep-disorderedbreathingresponsesofsubjectstoTNI(20L/min)arepresentedfortheclinicaltreatment night(TNIon)andthebaselinediagnosticnight(TNIoff).Two maineffectscanbediscerned.First,TNIledtoareductionin theoverall AHI(28 �5to10 �3events/h,p�0.01;Figure 4,left)andsomeimprovementoftheAHIwasobservedineach subject(Figure4,left).Ineightofthesesubjects,theAHIfell below10events/hour.Ofthethreeremainingsubjects,thenasal cannula dislodged for 2.5 hours in one subject (Figure 4, left, soliddiamonds), and hence the AHI fellonly minimallyfrom 19to17,whereasmoremarkedreductionsintheAHI,from46 to27andfrom39to23events/hour,wereobservedfortheother two(Figure4,left,barsandplussymbols). Second,TNIresponsesinhypopneasandapneasareshown separately (Figure 4, middle and right, respectively). TNI decreasedthehypopneaindex(Figure4,middle)from18 �2to 8 �2events/hour(p �0.01),andalsoreducedthenumberof obstructiveapneasinthethreesubjectswhohadanapneaindex greaterthan10events/hourduringsleep(subjects9,10,and11in Table1,andrepresentedbyplus,bar,andsolidtrianglesymbols, respectively,inFigure4,right).Ascanbeseen,apneicsubjects 9,10,and11hadareductioninapneaindexfrom36to17,from 17to11,andfrom35to6eventsperhourofsleep,respectively, suggestingthatTNIcandecreaseapneasaswellashypopneas. Assessmentofinterratervariabilitywasperformedwithanintraclasscorrelationcoefficient(ICC)forobstructiverespiratoryevents(ICC,1.0),respiratoryarousals(ICC,0.98),andspontaneousarousals(ICC,0.8),indicatinggoodagreementbetweenreviewersinallcategories;disagreementsbetweenreviewerswere minor(Table2). Figure2. Airflow and supraglottic pressure (Psg)responsetotreatmentwithnasalinsufflation (TNI) in one subject(subject1).During baseline, with TNI off (left),largeswingsinsupraglotticpressureand flattening of the inspiratory airflow contour occurredassupraglottic pressure continued to fall,indicatingupperairway obstruction (left). Whereas TNI at 10 L/ minute had no significant effect on airflow andsupraglotticpressure swings(middle),TNIat20L/minuteincreasedend-expiratoryPsgfrom0to2.2cmH 2O,whichwasassociatedwithanincreaseinpeakinspiratory airflowfrom290to360ml/second,andrespiratoryeffortmarkedlydeclinedasindicatedbyreductionsofthesupraglotticpressureswingsfrom –15to–3cmH 2O.
TNI ® Studies Therapy Diagnostics McGinley,Patil,Kirkness,etal.:ObstructiveSleepApneaTreatment 197 Figure3. Effectoftreatmentwithnasalinsufflation(TNI)onobstructivehypopneasinonesubjectduringnon–rapideyemovement(NREM)sleep. Left:TNIoff.Right:TNI20L/minute.Horizontallinesbelowtheflowsignaldemarcateindividualhypopneaeventswithoxyhemoglobindesaturations of4and3%,respectively.NotethemarkeddeclineinthesnoringsignalonTNIcomparedwithTNIoff.Microphone �digitallydisplayedsnoring auditorysignal;Psg �supraglotticcatheterpressure(cmH 2O);Sa O2 �oxygensaturation. Mechanism of Action Toexploretheunderlyingmechanismsresponsiblefortheeffect of TNI on sleep-disordered breathing we assessed inspiratory airflow,end-expiratorysupraglotticpressure,andrespiratoryeffortinasubgroupofsubjects(n �7).InFigure5,theimmediate respiratory responsesto TNIatarateof20 L/minuteforone subject with obstructive hypopneas are demonstrated. As can be seen in Figure 5, breaths off TNI were characterized by inspiratoryflowlimitationindicatedbyaplateauingofinspiratoryflowassupraglotticpressurecontinuedtofall(seeinspiratory flow limitation threshold marked by the horizontal dashed line).AfterTNIwasinitiated,therewasaninstantaneousincrease Figure4.Sleep-disordered breathingindices.Shown are apnea and hypopneaindicesduringthe baseline(Bsl)diagnostic night and the clinical treatmentnightforindividual subjects. Individual subject symbols areconsistentbetween panels.TNI �treatment withnasalinsufflation. 47
Page 1 and 2: PRODUCT CATALOGUE We like to suppor
Page 3 and 4: Index Therapy Diagnostics Product O
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Page 7 and 8: Products TNI ® products TNI ® - T
Page 9 and 10: Products ADVANTAGES: Therapy Diagno
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