SUBJECT: High Frequency Oscillation Policy DEPARTMENT: Intensive Care Services REFERENCE # 03-01-0060 INTRODUCTION This Adult Respiratory

Ventilator Protocol (RVP) has been developed for patients requiring High Frequency Oscillatory Ventilation and is based on goal orientated respiratory expectations. This protocol is set to ensure that evidence based best practice ventilator management is provided in designated areas 7 days a week/ 24 hours a day. All RVP care is initiated by an authorized physicians written order. Regardless of RVP exclusion criterion, all ventilated adult patients will be assessed and treated according to Respiratory Care Practitioner (RCP) Services best practice standards. The following RVP exclusion criteria will discontinue RVP and require physician management: 1. Patient is < 12 years of age. 2. Weight < 35 kg. 3. Terminal patient not for aggressive ventilation. Initial and subsequent ventilator parameter settings (per RVP) are to be documented on the Patient/Ventilator Flow Sheet. The acceptable protocol parameters are to be documented in the Patient Care Plan / History Sheet as care planning is performed (< 24hrs) during daily care planning rounds. Duplication of these parameters on the Doctors Order Sheet is not required. BACKGROUND Critically ill patients with acute respiratory distress syndrome (ARDS) require support with mechanical ventilation. However, ventilator-induced lung injury contributes to the high mortality (40-70%) of ARDS. Lung-protective ventilation has demonstrated important mortality reductions. High-frequency oscillation (HFO) is a novel form of ventilation in adults that has been widely and effectively used in neonates and children for ~20 years. HFO uses very small tidal volumes at high respiratory rates. Because tidal volumes are very low, HFO is theoretically better suited for lung protection than any conventional ventilator. This physiological rationale has inspired a growing literature and the rapidly expanding clinical use of HFO. Page: 1 Of: 8

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SUBJECT: High Frequency Oscillation Policy DEPARTMENT: Intensive Care Services REFERENCE # 03-01-0060 VENTILATION STRATEGY Our goal is to promote an open lung approach. We initiate HFO with 1 or 2 recruitment maneuvers (RMs) to open the lung. To keep the lung open we use relatively high mean airway pressures (mPAW). Mean airway pressure (mPAW) and inspired oxygen (FiO2) are titrated according to arterial oxygenation (PaO2 and SpO2). Our goal is also to minimize tidal volumes. Tidal volume during HFO is inversely related to frequency; thus we increase frequency as high as possible while avoiding severe respiratory acidosis. Frequency is therefore determined by pH. Initial Recruitment Maneuver (RM) With the oscillating membrane paused (P = 0), connect the patient to the HFO circuit and perform a RM, applying a distending pressure of 40 cm H2O for 40 seconds (or follow RM Protocol while patient is still connected to a conventional ventilator). The Lung Recruitment Maneuver (RM) When to Perform a RM on HFO: On initiation of HFO Immediately preceding any increase in mPAW dictated by the mPAW/FiO2 chart; after day 2 this is optional at the discretion of the attending physician If a persistent desaturation (SpO2 <88% lasting more than 15 minutes) occurs following an event likely to have caused derecruitment (e.g. suctioning, accidental ventilator disconnection, patient repositioning) ; after day 2 this is optional at the discretion of the attending physician **After 4 RMs on any given calendar day, further RMs will be optional at the discretion of the attending physician, even if indicated by one of the criteria above** Page: 2 Of: 8

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SUBJECT: High Frequency Oscillation Policy DEPARTMENT: Intensive Care Services REFERENCE # 03-01-0060 How to Perform a RM: a) Increase FiO2 to 1.0 b) Set the high pressure alarm to 55 cm H2O c) Pause the oscillating membrane (P = 0) d) Eliminate a cuff leak, if present (see below*) e) Slowly raise mPAW to 40 cm H2O over 10 seconds (see below) f) Maintain mPAW = 40 cm H2O over 40 seconds (see below) g) Slowly lower mPAW over 10 seconds: To the set level prior to the RM if the RM was conducted for a disconnect or Derecruitment To the level dictated by a step to the right on the mPAW/FiO2 chart if the RM was for persistent hypoxemia h) Resume oscillation and reset alarm limits i) Lower FiO2: To the set level prior to the RM if the RM was conducted for a disconnect or Derecruitment To the level dictated by a step to the right on the mPAW/FiO2 chart if the RM was for persistent hypoxemia **If a cuff leak is present, this leak will be eliminated prior to the performance of a RM. Following completion of the RM, adjust the mPAW setting (since the bias flow still at its increased level) to raise the mPAW to 5 cm H2O above the target setting, then reinstate the cuff leak, reducing mPAW to target. If the current set mPAW is > 30 cm H2O, at the discretion of the attending physician, a distending pressure of 45-50 cm H2O may be used for the RM. Early Termination of a RM: If any of the following occur during a RM, return the mPAW to the set level prior to the Director of Department Director of Medical Administration Program Director Page: 3 Of: 8

SUBJECT: High Frequency Oscillation Policy DEPARTMENT: Intensive Care Services REFERENCE # 03-01-0060 maneuver immediately (before completing the 40 second hold): Mean arterial pressure < 60, or fall of > 20 mm Hg SpO2 < 84% Heart rate > 140 or < 60 per minute New arrhythmia New air leak through a thoracostomy tube Initial Settings After the initial RM, RTs initiate HFO with the following settings: FiO2 1.0; inspiratory to expiratory (I:E) ratio 1:2 (1-time 33%) may increase to 50% with difficult oxygenation; bias flow 30 L/min; pressure amplitude (P) 20 cm H2O + PaCO2 from baseline ABG and chest wiggle to midthigh; mPAW 5 cm H2O above mPAW conventional ventilation frequency is determined by the arterial pH immediately prior to starting HFO [<7.10 = 3.5 Hz; 7.10-7.19 = 4 Hz; 7.20-7.35 = 5 Hz; >7.35 = 6 Hz]. Titrating Oxygen Support After the Initial RM For oxygen saturation (SpO2) > 90%, FiO2 is reduced in increments of 0.05 to 0.1 every 2-5 minutes to a target SpO2 of 88 93%. If the resultant FiO2 0.60 o Oxygenation support follows the mPAW/FiO2 chart (Section 4.3). If the resultant FiO2 > 0.60 o RTs perform a second RM on FiO2 1.0, applying a distending pressure of up to 45-50 cmH2O (at the physicians discretion) o HFO is reinitiated, with mPAW 34 cm H2O o Oxygenation support then follows the mPAW/FiO2 chart Maintenance of HFO: Adjustments for Oxygenation Page: 4 Of: 8

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SUBJECT: High Frequency Oscillation Policy DEPARTMENT: Intensive Care Services REFERENCE # 03-01-0060 Goals are SpO2 = 88 93% and PaO2 = 55 80 mm Hg Titrate mPAW and FiO2 according to oxygenation. When PaO2 and SpO2 data dictate different responses, PaO2 takes precedence. To maintain oxygenation goals clinicians follow this PAW/FiO2 chart:
Step Fi02 mPaw 1 0.4 20 2 0.4 22 3 0.4 24 4 0.4 26 5 0.4 28 6 0.4 30 7 0.5 30 8 0.6 30 9 0.6 32 10 0.6 34 11 0.7 34 12 0.8 34 13 0.9 34 14 1.0 34 15 1.0 36 16 1.0 38

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Employ the lowest FiO2/mPAW combination that achieves oxygenation in the target Range keeping as far to the left as possible). Setting mPAW at the target value, small respiratory fluctuations (5 cm H2O) around the set mPAW level are allowable unless oxygenation or ventilation is compromised; otherwise, more sedation is required. Each increase in mPAW is preceded by a RM. Physicians may discontinue these routine RMs at their discretion after 48 hours in study. Do not reduce mPAW by more than 2 cm H2O every two hours. Deviating from the mPAW/FiO2 chart If a patient develops hypotension during mPAW titration, use of lower mPAW may be indicated. If hypotension occurs during a RM, stop immediately and return mPAW to its most recent level. If hypotension occurs outside the setting of a RM, reduce the mPAW to 30 cm H2O, or to the most recently tolerated mPAW, whichever is lower. These patients should be investigated and treated to ensure that their intravascular volume is adequate; those who remain hypotensive despite adequate preload should receive intravenous vasopressors. If a patients lungs appear over distended, and/or they are unresponsive to increments in mPAW, a lower mPAW may be indicated. This may be most applicable when a patients severity of hypoxemia seems out of keeping with the extent of airspace disease seen on their current chest X-ray. In this setting, if a patient requires FiO2 > 0.6 for greater than 2 hours and intravascular volume has been optimized, clinicians may trial a lower mPAW at the discretion of the physician:

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SUBJECT: High Frequency Oscillation Policy DEPARTMENT: Intensive Care Services REFERENCE # 03-01-0060 If oxygenation worsens: o Raise the mPAW back towards its previous level If oxygenation is stable or improved: o Leave the mPAW at the reduced level o Wean FiO2 as tolerated until a listed combination on the FiO2/mPAW chart is reached o Continue adjusting FiO2 and mPAW according to the chart Maintenance of HFO: Adjustments for Ventilation (CO2 clearance) Goal is pH = 7.25 7.35 at the highest possible frequency To minimize Vt employ a strategy that maximizes frequency (f). Adjust frequency rather than P to control pH according to the instructions below: If pH > 7.35: o Increase f by 1 Hz every 30 60 minutes until pH is in goal range or f = 10 Hz. o Decrease P from 90 cm H2O only if f = 10 Hz and pH > 7.35 (without a cuff leak). If these criteria are met, decrease P by 10 cm H2O every 30 60 minutes until pH is in goal range. If pH = 7.25 to 7.35 o Use highest possible frequency within this goal range. If pH = 7.15 to 7.24: o Decrease by 1 Hz every 30 60 minutes until pH is in goal range or = 4 Hz If pH < 7.15 o Decrease by 1 Hz every 30 60 minutes until pH is in goal range or = 3 Hz o Consider intravenous bicarbonate infusion If pH < 7.05 o Ensure paralysis If pH < 7.05 for more than 1 hour with paralysis o Clinicians may deviate from assigned HFO protocol at the discretion of the attending physician, using HFO, conventional ventilation, or other respiratory adjuncts (rescue therapy). If a frequency of 6 Hz or higher cannot be achieved: Page: 6 Of: 8

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SUBJECT: High Frequency Oscillation Policy DEPARTMENT: Intensive Care Services REFERENCE # 03-01-0060 Page: 7 Of: 8

o Institute a partial (5 cm H2O) cuff leak as follows: Oral suction & set high pressure alarm to 55 cm H2O Increase bias flow until mPAW rises by 5 cm H2O Slowly remove air from the cuff until mPAW returns to previous level Return alarm limits to previous setting Increasing acidosis at any time should prompt clinicians to consider each of the following: o Unintentional reduction in the level of sedation or paralysis o Partial obstruction or malposition of the endotracheal tube; bronchoscopic inspection should be considered o Dysfunction of filter and/or water trap on pressure valve scavenger (if used) o Reduced chest wall compliance (e.g. eschar, massive ascites, gastric distention, pneumothorax, etc.) Transitioning back to Conventional Ventilation (CV) Once a patient has reached Step 2 or 3 of the mPAW/FiO2 chart (FiO2 0.4; mPAW 22 24), has been stable on these settings for at least 4-6 hours, and has been on HFO for at least 24 hours, at the discretion of the attending physician, consider conversion to CV for weaning. If a patient has been at Step 1 (FiO2 0.4; mPAW 20) for at least 4-6 hours, and on HFO at least 24 hours, conversion to CV is mandatory. When changing to the conventional ventilator, the endotracheal tube may be clamped briefly during the transition to avoid derecruitment. Switch to PCV (initial settings): peak pressure titrated to achieve delivered TV 6 ml/kg, Pplat < 30 - 35 cmH2O), FiO2 1.0 I:E 1:1 to 1:3, to avoid autoPEEP formation, PEEP 15 cmH2O, rate 20 25; to match previous VE, mPaw should be 20 cmH2O (+/- 2 cmH2O). However, if any of the following conditions is met, return them to HFO:

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SUBJECT: High Frequency Oscillation Policy DEPARTMENT: Intensive Care Services REFERENCE # 03-01-0060 Page: 8 Of: 8

If SpO2 < 88% on PEEP 14, FiO2 0.4 (or requirement for PEEP/FiO2 setting greater than these to maintain adequate SpO2) for > 1 hour If PPLAT (driving pressure + PEEP) > 30 cm H2O with VT up to 8 ml/kg IBW If pH falls to < 7.15 despite efforts to augment minute ventilation within the CV strategy (increases in tidal volume > 6-8 ml/kg are prohibited) If transition failure occurs within 3 hours of moving to CV, HFO will be re initiated with a RM and then all prior HFO settings will be resumed. If transition failure occurs after more than 3 hours, HFO will be restarted. Routine Ventilatory Care Elevate head of bed 30 degrees unless otherwise contraindicated. Use in line suction catheters to avoid unnecessary disconnections of the ventilator circuit from the endotracheal tube When a disconnection of the ventilator circuit is planned, consider clamping the endotracheal tube briefly during the transition to avoid derecruitment

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