3100 B Ventilator 3100 B Ventilator Approved for

3100 B Ventilator

3100 B Ventilator • Approved for sale outside the US in 1998 for patients weighing > 35 kg failing CMV • Approved September 24, 2001 by the FDA for sale in the US VIASYS Healthcare, Inc.

Pulmonary Injury Sequence • There are two injury zones during mechanical ventilation • Low Lung Volume Ventilation tears adhesive surfaces • High Lung Volume Ventilation overdistends, resulting in “Volutrauma” • The difficulty is finding the “Safe Window” Froese AB, Crit Care Med 1997; 25: 906 VIASYS Healthcare, Inc.

High Frequency Ventilation • Advantages • Enables ventilation above the “closing volume” with lower alveolar pressure swings. • Safe way of using “Super PEEP”. VIASYS Healthcare, Inc.

Theory of Operation • Controls for Oxygenation and Ventilation are mutually exclusive. • Oxygenation is primarily controlled by the Mean Airway Pressure (Paw) and the Fi. O 2. • Ventilation is primarily determined by the stroke volume (Delta-P) and the frequency of the ventilator. VIASYS Healthcare, Inc.

Large Patient Strategies • When to consider HFOV use? • As with all candidates, the earlier the better • Fi. O 2 >60, PEEP>10 with Pa. O 2/Fi. O 2 ratio<200 • Relative contra-indications • Obstructive lung disease • Elevated ICP VIASYS Healthcare, Inc.

Acute Respiratory Distress Syndrome VIASYS Healthcare, Inc.

19 yo female - Pneumococcal pneumonia (Day 1) Fi. O 2 100%, PEEP 20, PIP 60, Sp. O 2 80% VIASYS Healthcare, Inc.

19 yo female - Pneumococcal pneumonia (Day 2) Fi. O 2 100% Sp. O 2 - 78% VIASYS Healthcare, Inc.

19 yo female - Pneumococcal pneumonia (Day 3) Fi. O 2 100% and Sp. O 2 70% VIASYS Healthcare, Inc.

What if physiologic goals can’t be met using lung protective strategies? VIASYS Healthcare, Inc.

Large Patient Strategies • ARDS • Fi. O 2 matched • Paw 5 cm. H 2 O above CMV • Power of 4. 0 and then adjust for good CWF • Bias flow >20 lpm, higher if required to maintain Paw • Frequency determined by patient size and compliance • I-Time set to 33% VIASYS Healthcare, Inc.

Oxygenation Strategies • Paw until you are able to Fi. O 2 to 60% with a Sa. O 2 of 90% • Avoid hyperinflation • Optimize preload, myocardial function Ventilation Strategies – CWF- adjust Power Setting to target Pa. CO 2 to between 45 -55 mm. Hg – frequency by 1 Hz increments if Amplitude is maximized – Induce cuff leak – allow permissive hypercarbia if indicated, keeping p. H>7. 25 VIASYS Healthcare, Inc.

HFOV Strategy • If CO 2 retention persists, decreasing cuff pressure to allow gas to escape around the ET tube will move the fresh gas supply from the wye connector to the tip of the ET tube VIASYS Healthcare, Inc.

Clinical Tips • Failure Criteria • Inability to decrease Fi. O 2 by 10% within the first 24 hrs. • Inability to improve ventilation or maintain ventilation (after optimizing both frequency and amplitude) with Pa. CO 2 < 80 with p. H > 7. 25. • A transcutaneous monitor is useful for trending CO 2. VIASYS Healthcare, Inc.

Clinical Assessment • Suctioning • Indicated by decreased or absence CWF, decrease in O 2 saturation, or an increase in Tc. CO 2. • Remember that each time the patient is disconnected from HFOV, they will potentially de-recruit lung volume. • Closed suction catheters may mitigate • de-recruitment • It may be necessary to temporarily Paw or perform recruitment maneuver VIASYS Healthcare, Inc.

Derecruitment during Disconnect • Minimize suction • attempts • Use closed suction systems • Avoid unnecessary disconnects • May require RM or Fi. O 2 to return Sa. O 2 to baseline VIASYS Healthcare, Inc.

Clinical Assessment • Chest Wiggle factor (CWF) must be evaluated upon initiation and followed closely after that. • CWF absent or becomes diminished is a clinical sign that the airway or ET tube is obstructed. • CWF present on one side only is an indication that the ET tube has slipped down a primary bronchus or a pneumothorax has occurred. Check the position of the ET tube or obtain a CXR. • Reassess CWF following any position change. VIASYS Healthcare, Inc.

Clinical Assessment • Chest X-rays • Obtain the first x-ray at the (4) hour mark to determine the lung volume at that time. Paw may need to be re-adjusted accordingly. • Always obtain a CXR , if unsure as to whether the patient is hyper-inflated or has de-recruited the lung. VIASYS Healthcare, Inc.

Clinical Assessment • Auscultation • Breath sounds-listen to the “intensity or sound” that the piston makes, it should be equal throughout. • Heart Sounds - stop the piston, (the patient is now on CPAP); listen to the heart sounds quickly, and restart the piston. VIASYS Healthcare, Inc.

Clinical Tips • Weaning • Wean Fi. O 2 for arterial saturation > 90% • Once Fi. O 2 is 60% or less, re-check chest x-ray and if appropriate inflation, begin decreasing the Paw in 1 cm. H 2 O increments • Wean Delta-P in 5 cm. H 2 O increments for Pa. CO 2 • Once the optimal frequency is found, leave it alone VIASYS Healthcare, Inc.

Aerosol Therapy • Patients who are actively wheezing or have RAD • administration via bagging- try to coordinate with suctioning • IV terbutaline for patients who do not tolerate disconnects • promising new nebulizer technology VIASYS Healthcare, Inc.

Practical Considerations • Humidification of bias flow accomplished with a traditional heated humidifier • Longer, flexible circuit allows patient positioning to prevent skin breakdown • Infection control issues VIASYS Healthcare, Inc.

Managing Large Patients • Most patients will require heavy sedation and occasional neuromuscular blockers to be maintained on the 3100 B. VIASYS Healthcare, Inc.

HFOV Management Guidelines for Transition to CMV • Paw < 24 cm. H 2 O or stalled • Fi. O 2 < 50% or stalled • > 4 days HFOV • Return to CMV at similar Paw VIASYS Healthcare, Inc.

3100 B Rescue Trial • Fort P, et al. High-frequency oscillatory ventilation for adult respiratory distress syndrome-a pilot study. Crit Care Med 1997; 25: 937 -947 • Seventeen patients failing inverse ratio ventilation recruited for rescue with HFOV (3100 B) • Predicted mortality > 80 percent VIASYS Healthcare, Inc.

3100 B Rescue Trial Fort P, Crit Care Med 1997; 25: 937 VIASYS Healthcare, Inc.

3100 B Rescue Trial Fort P, Crit Care Med 1997; 25: 937 VIASYS Healthcare, Inc.

Multicenter Oscillator ARDS Trial • Prospective Randomized Controlled Trial of the Sensor. Medics 3100 B HFOV for adults with ARDS • Follow-up to MOAT Pilot Rescue Trial • Early Entry, Non-Crossover Trial • Ten Institutions, North American Study Derdak, AJRCCM 2002 VIASYS Healthcare, Inc.

Patient Demographics - Baseline N Age Kg Apache II Sepsis Pneumonia Trauma Immune Compromised Airleak HFOV 75 48 (17) 78 (25) 22 (6) 47% 19% 21% 12% 16% CV 73 51 (18) 81 (26) 22 (9) 47% 16% 18% 14% 19% *NS VIASYS Healthcare, Inc.

Ventilator Strategies - Goals • Normalize lung volume • Minimize peak ventilator pressures • Physiological targets included: • Oxygen Saturation > 88% • Delay weaning m. Paw until Fi. O 2 < 50% • p. H > 7. 15 • Pa. CO 2 in the range of 40 – 70 mm. Hg VIASYS Healthcare, Inc.

Primary Outcome: Status at 30 d N Died Alive + RS Alive - no RS HFOV CMV 75 37%* 41%** 21% 73 52% 26% *P=0. 098 ** HFOV 61% on vent vs CMV 73% on vent VIASYS Healthcare, Inc.

MOAT 2 - Secondary Outcomes HFOV(n=75) Blood Pressure Airleak O 2 Failure (OI >42 after 48 h) p. H < 7. 15 Mucus Plug 0% 9% 5% 5% 5% CV(n=73) 3% 12% 8% 8% 4% *NS VIASYS Healthcare, Inc.

MOAT 2 Conclusions • Based on a study of 148 patients, use of HFOV for the treatment of severe ARDS resulted in an absolute reduction in mortality by 15%. • This reduction trend in mortality is still recognizable at six months in this same population. • There may also be benefits related to chronic lung change as reflected by the small but extended use of respiratory support in the conventional ventilation managed patients. VIASYS Healthcare, Inc.

MOAT - Comparison with ARDSnet MOAT 30 d mortality P/F Paw PEEP OI Sepsis 37% 114 22 13 24 47% ARDSnet (6 ml/kg) 31% 138 17 9 12 27% ARDS NET, NEJM 2000 VIASYS Healthcare, Inc.

Changing Medical Practice • Changing Medical Practice is the Most Difficult Task • 6 ml/kg tidal volume ventilation for ARDS Compliance with LPV Day 0 Day 3 Day 7 Before publication 3% 6% 9% After publication 1% 3% 7% • Reasons of Non-Compliance • Reluctance to give up control to a protocol • Patient comfort • Acidosis • Oxygenation • Therefore: • Most patients with ARDS are not managed with LPV • HFOV has the potential to remove most barriers to use of LPV Ru benfeld GD et al ATS 2001 VIASYS Healthcare, Inc.

A Prospective Trial of HFOV in Adults with ARDS • Patient Population • 23 Adults 10 F, 13 M • Age 48 + 15 yrs • Weight 72 + 17 kg • Apache II 21 + 7 • LIS 3. 4 + 0. 6 • Diagnosis • Pneumonia/Sepsis 12 • Burn 5 • Bone Marrow Transplant 4 • Other 2 Mehta et al. CCM 2001; 1360 -1369 VIASYS Healthcare, Inc.

A Prospective Trial of HFOV in Adults with ARDS • Patient Population • Prior Vent Days • Pa. O 2/Fi. O 2 (mm Hg) • OI (Fi. O 2 x. Paw x 100/Pa. O 2) • Pressures during CMV • PIP (cm. H 2 O) • Paw • PEEP 6. 1 + 5. 6 days 100 + 41 33 + 20 37 + 4 24 + 3 13. 8 + 2. 4 Mehta et al. CCM 2001; 1360 -1369 VIASYS Healthcare, Inc.

A Prospective Trial of HFOV in Adults with ARDS • Outcomes • Reason for HFOV withdrawal – Successfully weaned – Withdrawal of life support/death – Technical problem • ICU Survival – Nonburn patients – Burn patients 10 11 2 7/23 (30%) 7/17 (41%) 0/5 Mehta et al. CCM 2001; 1360 -1369 VIASYS Healthcare, Inc.

A Prospective Trial of HFOV in Adults with ARDS • Days of Prior Ventilation • Non Survivors 7. 8 + 5. 8 days • Survivors 1. 6 + 1. 2 days Mehta et al. CCM 2001; 1360 -1369 VIASYS Healthcare, Inc.

HFOV in Adults with ARDS • 42 patients failing CMV • Baseline P/F ratio = 99(+46) increased to 191(+121) after 24 hours without HFOV related adverse events. • 30 day mortality was 43% • Subset analysis showed higher 30 day mortality in patients on CMV>3 days(67%) M David et al ICM July, 2003 VIASYS Healthcare, Inc.

Rescue Therapy with HFOV: Don’t wait too late VIASYS Healthcare, Inc.

Adjunctive Therapies - i. NO • Post hoc analysis of 108 pediatric patients in a RCT with AHRF and i. NO • Comparisons • HFOV plus i. NO (n=14) • HFOV alone (n=12) • CMV plus i. NO (n=35) • CMV alone (n=38) Dobyns CCM 2002; 30(11): 2425 VIASYS Healthcare, Inc.

Conclusions • P/F ratio greatest in the HFOV plus i. NO group at 4 and 12 hours • After 24 hours, both the HFOV plus i. NO and HFOV alone resulted in greater P/F ratio improvement • Speculation that enhanced lung recruitment by HFOV enhances the effects of i. NO on gas exchange VIASYS Healthcare, Inc.

Adjunctive Therapies - Proning • Case report • 56 yo man d/w drug overdose and aspiration failing CMV and i. NO • transitioned to HFOV plus i. NO with improved ventilation • proning (q 6 -8 h) initiated due to worsening oxygenation • transitioned to CMV post 4 days, i. NO weaned after 9 days • patient subsequently weaned and discharged Anesthesiology 2001; 95(3)797 VIASYS Healthcare, Inc.

Unresolved Issues • • • What is the best way to set Paw What are the best recruitment strategies How are hemodynamic parameters best assessed How are aerosols best delivered How to best predict responders Does HFOV result in less VILI than a conventional lung protective strategy VIASYS Healthcare, Inc.

Take Home Messages • Ventilation Strategies do affect patient outcomes • Volume and pressure swings promote lung injury and mediator release. • Identify patients at risk for developing VILI earlybefore the fibroproliferative stage • Alternative therapies such as HFOV may offer lung protection that may improve outcomes for patients with ARDS VIASYS Healthcare, Inc.