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1 CareFusion Savi Ranch Parkway Yorba Linda, CA toll-free tel fax CareFusion Germany 234 GmbH Leibnizstrasse Hoechberg Germany tel fax CareFusion Yorba Linda, CA carefusion.com 2011 CareFusion Corporation or one of its subsidiaries. All rights reserved. RC (0811/5000) L3250 Rev. C

2 Pocket guide 3100B high frequency oscillatory ventilator

3 This clinician s guide describes equipment set-up and patient management procedures for the 3100B High Frequency Oscillatory Ventilator (HFOV). Warning Do not use this pocket guide as a substitute for (1) reading and understanding the operator s manual, (2) as a substitute for being properly trained or (3) as a substitute for competency using the 3100B High Frequency Oscillatory Ventilator. Use this document as a guideline for initiating and managing the patient on HFOV. Management of a patient on the 3100B HFOV must be altered based on the patient s individual clinical needs. This document is not intended to be used as a substitute for clinical experience or medical guidance. i

4 Contents Indications and contraindications...1 Things to consider before placing the patient on HFOV...4 Pre-use checklist...6 Patient circuit calibration...8 Ventilator performance check...10 Initial settings and management...12 Managing oxygenation and ventilation...16 Assessment of the patient on HFOV...18 Documentation of oscillator settings...21 Weaning HFOV and transitioning to conventional ventilation...22 Transitioning to conventional ventilation...23 Troubleshooting...24 Recruitment maneuvers for adult patients on HFOV...34 Cuff leak procedure...36 Outcome assessment form...41 Useful information...42 ii

5 Indications and contraindications Indications The 3100B High Frequency Oscillatory Ventilator is indicated for use in the ventilatory support and treatment of selected patients weighing 35 kilograms and greater with acute respiratory failure. Contraindications The 3100B High Frequency Oscillatory Ventilator has no specific contraindications. 1

6 Identifying patients for high-frequency oscillatory ventilation Patients with ALI or ARDS, weighing 35 kilograms or greater, who are currently failing on conventional ventilation with a protective lung strategy, will benefit from HFOV. The following criteria are generally used for determining the feasibility of using HFOV. FiO 2 60, PEEP 10 with a P/F ratio < 200 Plateau pressure > 30 cmh 2 O Presence of bilateral infiltrates on the chest x-ray consistent with ARDS Oxygenation index > 24 Note: Several clinical papers and randomized control trials have demonstrated that the earlier application of HFOV on patients with severe ARDS may be important for successful outcomes. 2

7 The Multicenter Oscillatory Ventilation for Acute Respiratory Distress Syndrome Trial 1 (MOAT2) excluded severe COPD and asthma patients from the RCT trial of the 3100B HFOV. High frequency oscillatory ventilation is recognized as less effective in diseases with increased airway resistance and using it in such cases may potentially result in air trapping and hyperinflation. 3

8 Things to consider before placing the patient on HFOV Hemodynamic status: The patient should be hemodynamically stable with a mean arterial pressure of at least 75 mmhg If mean arterial pressure is less than 75 mmhg, consider fluids and/or vasopressors to optimize the hemodynamic status before starting the oscillator Obtain ABG Ideally, ph should be greater than 7.2 If ph is less than 7.2, consider correcting with a buffer for the transition Patient s sedation status: You may need to consider sedation and neuromuscular blockades for transition due to the fixed Bias Flow of the device, patients are unable to actively breathe and maintain a stable airway pressure and lung volume Once transitioned, patients may be able to be maintained on sedation only 4

9 Ensure the patient has had a recent chest x-ray Consider the type of mattress the patient is on you should have the ability to firm up the mattress if needed Verify whether the patient requires an off-unit procedure such as a CT scan or MRI; if this is the case, consider doing the off-unit procedure before placing the patient on HFOV If using an in-line suction catheter, ensure the fit to the circuit and suction patient before placing on HFOV Give a brief explanation of HFOV to the family and patient to prepare them for noise, chest wiggle, etc. If lung recruitment maneuvers are not part of your ventilation protocol, speak with the physician to consider Treatment with Oscillation and Open Lung Strategy (TOOLS) 2 5

10 Pre-use checklist 1. Connect the source gases to system. 2. Connect the power to system. 3. Check that the patient circuit support is installed on the system. 4. Connect the patient circuit and the humidifier to the system. 5. Connect the patient circuit control and pressure sense lines to the system. 6. Turn on the power. 7. Check that the source gas lights are off. 8. Check that the start/stop light is off. 9. Check that the alarm silence light is on. 10. Perform the patient-circuit calibration described in the following section. 11. Perform verification performance. 12. Perform the alarm-check procedure as described in the Operators Manual. 6

11 13. Preset the flow, frequency, % inspiratory time, power and running mean airway pressure. 14. Set the Max Paw and Min Paw switches. 15. Set the blender and humidifier controls for the desired operation. 16. Remove the stopper from the patient circuit and connect it to the patient s ET tube. 7

12 Patient circuit calibration Perform the patient circuit calibration procedure before ventilating a patient. Each circuit that is used on the oscillator must be calibrated. The circuit calibration procedure verifies the circuit is leak-free and will hold pressure. Perform this procedure before placing a patient on the 3100B HFOV and anytime a circuit component is changed. 1. Insert the stopper in the patient circuit wye and turn on the bias flow gas. 2. Rotate the ADJUST control to Max. 3. Set the Max Paw Alarm to 59 cmh 2 O. 4. Set the bias flow to exactly 20 LPM (the middle of the ball is at the line you may need to bend down to see this accurately.). 5. Depress and hold RESET (Oscillator OFF). 8

13 6. Observe the mean pressure display and adjust the patient circuit calibration screw for a reading of 39 to 43 cmh 2 O. a. Before adjusting the calibration screw, confirm there are no leaks, the bias flow is at 20 LPM and the circuit is set up correctly. See the troubleshooting guide for more information. b. Use caution when adjusting the calibration screw. Do not over tighten or apply excessive force because equipment damage may occur. 9

14 Ventilator performance check The ventilator performance check ensures the 3100B HFOV is functioning properly. Perform this procedure before placing a patient on the 3100B HFOV. Insert the stopper in the patient circuit wye and turn on both gas sources. 1. Turn the Adjust control to the 12 o clock position. 2. Set the bias flow at 30 LPM. 3. Pressurize the system by pressing and holding Reset and Adjust for a mean pressure of 29 to 31 cmh 2 O. 4. Set the frequency to 6.0 Hz, % I time to 33 and press START/STOP to start the oscillator. 5. Set the power to Observe the following parameters using the appropriate altitude range and verify they fall within the ranges specified. 10

15 Verify the following parameters according to the altitude of your hospital. Altitude (feet) mpaw (cmh 2 O) P (cmh 2 O) 0 to 2, to to 135 2,000 to 4, to to 125 4,000 to 6, to to 115 6,000 to 8, to to 105 Note: See troubleshooting on pg. 22 for additional information. 11

16 Initial settings and management 1. Set bias flow between 25 to 40 LPM. Patients with severe air-leak syndrome or cuff leak may require higher set Bias Flow to achieve the desired mpaw. 2. Set the initial mean airway pressure (mpaw) at 5 cmh 2 O pressure above the conventional ventilator mpaw. a. You may consider a recruitment maneuver first if the patient is extremely hypoxic by applying 40 cmh 2 O for 40 to 60 seconds. b. If oxygenation worsens, increase mpaw in 3 to 5 cmh 2 O increments every 30 minutes until the maximum setting is reached. Note: Oxygenation typically may worsen in the first 30 minutes of recruitment in severe ARDS. 12

17 c. Check a chest-x-ray within one to four hours of initiating HFOV to assess lung volume. 3. Set the power at 4.0 and rapidly increase it to achieve chest wiggle (a visual vibration from shoulders to mid-thigh area). a. Transcutaneous monitoring for CO 2 (TcCO 2 ) should be considered. b. If PaCO 2 worsens (but ph > 7.2), increase the power setting to achieve a change of amplitude in 10 cmh 2O pressure increments every 30 minutes up to the maximum setting. c. If ph is < than 7.2, consider buffering ph. d. An abrupt rise in PaCO 2 in an otherwise stable patient should be considered an obstruction of the endotracheal tube until proven otherwise. Note: Some studies suggest a higher frequency setting (and corresponding higher amplitude) may be more lung-protective. 13

18 4. Set Hz at a range of 5 to 6 initially. a. You may decrease the Hz if you cannot control the PaCO 2 with amplitude of approximately 90 cmh 2 O. b. Decrease the Hz by 1 Hz at a time every 30 minutes until you reach a level of 3 Hz. 5. Set IT % at 33%. You may increase this value up to 50% if you are unable to ventilate by increasing the amplitude or by first decreasing the frequency. Caution! Using flows higher than 40 LPM may increase the risk of increasing PaCO 2 due to decreasing the effectiveness of the active exhalation. 6. For severe hypercapnea with ph > 7.2, consider decreasing the endotracheal tube cuff inflation to produce a leak. a. Reduce the inflation of the cuff until you see a drop in the mpaw by 5 cmh 2 O. Readjust the bias flow to correct the mpaw level. b. Rule out obstruction in endotracheal tube with bronchoscopy. 14

19 7. Initial FiO 2 at transition to HFOV should be set to 1.0. Alternatively, increase current FiO 2 by 10%. 8. As oxygenation improves, gradually wean FiO 2 to 0.40, and then slowly reduce mpaw 2 to 3 cmh 2 O every four to six hours until mpaw is in a 22 to 24 cmh 2 O range. 9. When the above goal is met (but no sooner than 24 hours), switch to PCV or APRV. Initial settings: PIP titrated to achieve delivered Vt of 6 to 8 ml/kg Plateau Pressure (Pplat): < 35 cmh 2 O I:E of 1:1 PEEP: 12 cmh 2 O Rate: 20 to 25 / min Mean airway pressure should be about 20 cmh 2 O (± 2 cmh 2 O). 15

20 Managing oxygenation and ventilation If h PaO 2 1. Wean FiO 2 slowly (5%) to < Re-check the x-ray for lung volume assessment. If lung volume is adequate, continue to wean FiO 2 to If lung volume is approaching a hyperinflation state, consider weaning mpaw by 1 to 2 cmh 2 O and continue to wean FiO 2 to Once FiO 2 is < 0.40, attempt to wean mpaw by 1 to 2 every four to six hours, ensuring maintenance of adequate lung inflation and oxygenation. If i PaO 2 1. h FiO 2 as needed to h mpaw by 3 to 5 every 20 to 30 minutes to obtain adequate lung inflation and oxygenation. 3. Check the x-ray to ensure appropriate lung volume. 4. Check for hemodynamic status for adequate perfusion. 16

21 If h ph 1. i Power, maintaining adequate chest wiggle factor. 2. h Hz. 3. i % I-time to 33% if at 50%. If i ph 1. h Power, obtaining or maintaining adequate chest wiggle factor. 2. i Hz (minimum of 3.0). 3. Generate ETT leak. 4. h % I-time to 50% if at 33%. hi PaCO 2 1. Accept hypercapnia if ph allows (> 7.2). 2. You may consider buffering ph to allow permissive hypercapnia. 17

22 Assessment of the patient on HFOV ABG Sixty minutes post initiation of HFOV ABG frequency based on clinical status Within one hour of any major settings change or as clinically indicated CXR Within one to four hours post initiation of HFOV Whenever lung over-inflation or under-inflation is suspected 18

23 Patient assessment Patient assessment should be done every two hours and should include the following: 1. Chest wiggle factor (CWF): Visible vibration noted from the shoulder to mid thigh and bilateral. This check ensures movement of air through the airway structure and lung. a. Check for the degree of vibration noted and symmetry. b. Question changes in CWF, for example: Increase with improvement in compliance. Decrease with worsening in compliance or presence of secretions. Noted only on one side of the chest due to ET tube slipping down main bronchus or presence of a pneumothoraces. 2. Auscultation: Breath sounds cannot be heard; however, you may denote changes in the intensity of the piston sounds. 3. Heart and GI sounds: Stop piston temporarily, lung inflation will be maintained. 19

24 4. Vital signs: HR, BP, MAP, urine output, PCWP, PAP and CVP monitoring are not required, but useful tools in ensuring adequate perfusion. 5. Oxygen saturation should be maintained between 88 to 93%. 6. Most FiO 2 changes are made based on improvement in O 2 saturation. 7. Transcutaneous PCO 2, if available, is useful for trending PaCO 2 and indication of ventilatory status change. 8. Monitor for adequate perfusion status by assessing capillary refill, skin turgor and color, urine output change and persistent metabolic acidosis. 9. Secretions will present problems with ventilation if present. Usually secretions are noted by a rapid rise in PaCO 2, a decrease in oxygen saturation and a visible decrease in chest wiggle. 10. If a cuff leak is used, monitor it closely during position changes. You may see changes in amplitude and mpaw reflected on the 3100B HFOV. 20

25 Documentation of oscillator settings Verify and record the ventilator settings (frequency, bias flow, % inspiratory time, power, Max Paw and Min Paw) and measurements (mpaw and amplitude). Note: If mpaw or amplitude measurements change independent of changing a setting, assess for clinical changes, circuit issues or airway issues before dialing for a given measurement. Presence of an intentional cuff leak FiO 2 (must be analyzed) 21

26 Weaning HFOV and transitioning to conventional ventilation When the goals below are met (but no sooner than 24 hours) switch to PCV. FiO 2 is weaned to 0.40 mpaw is 22 to 24 cmh 2O SpO 2 > 88% (or as ordered) The patient should be stable on the above settings and able to tolerate suctioning and brief disconnects. The chest x-ray should show resolution of the underlying process. 22

27 Transitioning to conventional ventilation 1. Use a mode most conducive to the patient; usually PCV/APRV. 2. Set the mean airway pressure to be the same in CMV as on HFOV. 3. Adjust inspiratory pressure to achieve Vt 6 to 10 ml/kg of ideal body weight. 4. Set PEEP, FiO 2 and rate based on most recent ABG. 23

28 Troubleshooting Troubleshooting clinical issues These clinical troubleshooting guidelines are to help orient you to a possible cause for a clinical change. These only address common problems and are by no means all inclusive. 24

29 Problem: The patient experiences an abrupt deterioration (with a rapid rise in PaCO 2 ) while being mechanically ventilated with the high frequency oscillator. Consider the following: Acute airway obstruction (mucous plug) Pneumothorax Bronchospasm Right mainstem intubation or extubation Responses under these circumstances: Assess airway function/patency (e.g., ETT suctioning, auscultation, direct laryngoscopy, tcpco 2 assessment, diminished chest wiggle) Recommend bronchoscopy Draw an ABG if the acute decompensation results in profound hypoxemia (SpO 2 < 80%) or acute hypotension (mean BP drop of > 20 mmhg) Notify the physician of these developments immediately and recommend a stat chest x-ray Consider removing the patient from the oscillator and hand resuscitating 25

30 Problem: The patient experiences an abrupt deterioration with a drop in oxygen saturation. Consider the following: Airway patency Changes in mean arterial pressure Disconnection from the HFOV device with loss of lung volume Possible pneumothorax Responses under these circumstances: Consider fluid boluses and/or pharmacologic support to maintain mean arterial pressure of 75 mmhg or greater Re-check the x-ray to assess or rule out presence of pneumothoraces For an accidental disconnect, consider a recruitment maneuver and/or increase FiO 2 initially 26

31 Problem: Hypotension. Increased intrathoracic pressure from the elevated mpaw may cause decreased blood flow resulting in reduced right ventricular preload. Consider the following: Fluid bolus Pharmacologic support Reduce mpaw 27

32 Troubleshooting equipment issues Circuit does not pass patient circuit calibration Visually check for leaks, cracks and open ports on the circuit Check cap/diaphragms Check the water trap stopcock (may be open or missing) Ensure the circuit set up is correctly Confirm the bias flow is set exactly at 20 LPM (the middle of the ball is at the 20 LPM line you may need to bend down to see this accurately) Check the airway pressure luer fittings for cracks Check the calibration screw (clicking indicates a defective valve) Confirm the pressure transducer zero: With the circuit stopper in place, but the system not pressurized, the Paw should read 0 cmh 2O (± 0.5 cmh 2 O) 28

33 Ventilator does not pass the performance check Low amplitude: Bypass the humidifier Check the power knob (0.0 to 10.0) Low mpaw (with or without low amplitude): Crimp the airway pressure line (mpaw should read 130 to 140 cmh 2 O) Check the flow meter Driver does not start oscillating: Check the power knob Check mpaw Check if the humidifier chamber is empty (may drop the amplitude by as much as 10 cmh 2 O) Bypass the humidifier 29

34 Fluctuating mpaw The Auto-Limit feature is activated Check the high-pressure setting Check for spontaneous breathing Low Source Gas is illuminated This condition indicates an input pressure of less than 30 psi from either the blender or the cooling air; check the input gas lines Ensure that all hoses are plugged into a gas source Check the blender setup configuration Some wye or T fittings used to split the high-pressure line have an internal restriction; remove the wye or T fitting to check it The input water trap filter needs to be replaced: Replace the filter Internal leak: Call CareFusion Technical and Clinical Support 30

35 High Pressure alarms (alarm setting or > 60 cmh 2 O) Spontaneously breathing: Consider the clinical status of the patient, assess the sedation level or insufficient bias flow rate; re-adjust mpaw using a higher flow Obstruction in the expiratory limb or in the pressure sense line: Replace the patient circuit Improper setting of the alarm: Change the alarm setting Patient circuit temperature rise: Check and correct the circuit temperature Interference from a radio transmitter: Remove the source of interference Low Pressure alarms (alarm setting or < 5 cmh 2 O) Spontaneously breathing: Consider the clinical status of the patient, assess sedation level or check for insufficient bias flow rate and re-adjust mpaw using higher flow Improper setting of the alarm: Change the setting Improper setting of the mpaw or flow meter: Change the setting Patient circuit temperature drop: Check and correct the circuit temperature 31

36 Leak in the humidifier or patient circuit: Fix the leak or replace the patient circuit Cap diaphragm leak: Replace the cap diaphragm The water trap stopcock is open: Close the water trap stopcock Interference from a radio transmitter: Remove the source of interference Oscillator stopped with no other alarm occurring The power setting is too low and the amplitude is to 7 cmh 2 O: Adjust setting for desired amplitude Oscillator failure: Call CareFusion Technical and Clinical Support Amplitude changed over the past couple hours while the Power setting remained unchanged Amplitude increased: Airway resistance increased and/or total lung compliance decreased Amplitude decreased: Airway resistance decreased and/or total lung compliance increased 32

37 Changes in amplitude are normal as the patient s pulmonary status changes; assess patient changes in status and adjust ventilator settings if deemed appropriate General guidelines Ventilator circuits should never be reused: Washing and sterilizing will reduce their overall performance and increase the risk of malfunction Use caution when storing ventilator circuits; some components of the circuits may break if compressed tightly Water exiting the exhalation valve is normal; the use of personal protective equipment or the filtered oscillator circuit is encouraged 33

38 Recruitment maneuvers for adult patients on HFOV A recruitment maneuver is a technique employed by attempting to recruit the alveoli and increase lung volume by using a sustained inflation accomplished by a set mpaw of 40 cmh 2 O pressure for 40 seconds with the piston in a stopped position. This technique, when combined with HFOV, is thought to provide further improvements in oxygenation and lung recruitment. 3 Technique: 1. Set FiO 2 to Inflate cuff. 3. Stop the oscillator (START/STOP button). 4. Increase the mpaw to 40 cmh 2 O; then maintain that pressure for 40 seconds. 5. Return to the previous oscillator settings. a. Decrease mpaw. b. Resume oscillation. c. Establish the previous cuff leak. 34

39 Recruitment maneuver guidelines 2 Perform a recruitment maneuver after any circuit disconnect Perform a recruitment maneuver before an increase in mpaw A recruitment maneuver may be repeated up to three times to see improvements in oxygenation with the ability to reduce FiO 2 Caution! Do not perform a recruitment maneuver under either of the following conditions: Pneumothorax is present with an active air leak Patient is hemodynamically unstable, for example: Mean arterial pressure < 60 mmhg or falls > 20 mmhg during the maneuver Heart rate > 140 and < 60 New arrhythmias are noted SpO 2 < 85% 35

40 Cuff leak procedure The cuff leak procedure was identified as a technique that may be employed with HFOV to assist with clearing tracheal dead space of CO 2 and assist with maintaining an adequate ph. Decreasing cuff pressure allows gas (PaCO 2 ) to escape around the ET tube and to be excreted through the mouth. In some cases PaCO 2 can drop by 30 to 40 mmhg (or more). However, it should be noted that if there is an active air leak from a chest tube, the effect of a cuff leak may be minimal or non-existent. CO2 O2 O2 36

41 Indications Power/amplitude and mpaw have been optimized with no net improvement in PaCO 2. Frequency has been lowered to four Hz or less with no improvement in PaCO 2. Inspiratory Time % has been increased with no improvement in PaCO 2. Procedure 1. With a syringe attached to the endotracheal tube pilot balloon, withdraw air. 2. Reduce the inflation of the cuff until you see a drop in the mpaw by approximately 5 cmh 2 O. 3. Increase the bias flow to correct to the desired mpaw level. Monitoring for cuff leak patency If mpaw increases, suction hypopharynx and reassess. If mpaw is lower than desired, reassess and re-adjust the cuff air pressure to the target mpaw level desired. Mean airway pressure may change after patient position changes; reassessment should be done after the change. 37

42 Caution! Before producing a cuff leak consider the following: The patient has been suctioned A bronchoscopy, if possible, was performed to clear airway of any obstruction A recent chest x-ray shows appropriate lung volume. Note that the distal mpaw will be less with cuff deflated even though the monitored mpaw is the same If oxygen saturation drops with this procedure, you may consider increasing mpaw 38

43 Table 1: PaO 2 / FiO 2 ratio < 200 ARDS < 300 ALI < 400 Abnormal > 400 WNL 39

44 Table 1: PaO 2 / FiO 2 ratio (continued) < 200 ARDS < 300 ALI < 400 Abnormal > 400 WNL 40

45 Outcome assessment form The use of this form is not intended to encourage or deny the use of high frequency oscillation. The following below is only a portion of the form. You can find the Outcome Assessment Form to print and use on the CareFusion site at carefusion.com/hfov/. Low risk (zero points) Moderate risk (one point) High risk (two points) Max risk (three points) Days P/F < 200 < 2 days 2-4 days 5-6 days > than 7 days Days of CMV < 6 days > 7 days PaCO < > 80 Organ failures pulmonary only 2 or more PIP < > 50 Immune comp. No Yes OI < > 41 OI trend Slowly Dramatically worsening worsening Oxygenation Index (OI) = [(FiO 2 x 100) x mpaw /PaO 2 ] Score: 1 7 Low anticipated mortality; 8 13 Moderate anticipated mortality; High anticipated mortality Score 41

46 Useful information Clinical and technical support for HFOV Registered respiratory therapists are available for clinical and technical support during normal business hours and for emergency support 24 hours per day. Call and follow the prompts. (For technical support in Canada call ) 3100B HFOV rental program The 3100B HFOV rental program is designed to assist customers who own the 3100B HFOV and need additional units or customers trained on the 3100B HFOV and approved to rent the device as a short term solution to bridge to a purchase. Delivery will be within 24 hours or less in most cases. This program is available 24 hours per day. Call and follow the prompts. 42

47 3100B HFOV intervention program The 3100B HFOV intervention program is designed to allow access to the device for centers that do not have trained personnel or have not maintained competency of the 3100B HFOV. The 3100B HFOV intervention program provides an onsite clinical consultant for education and clinical support. This program must be set up in advance. HFOV website carefusion.com/hfov/ Abbreviations ARDS ALI mpaw Paw Acute Respiratory Distress Syndrome Acute Lung Injury Mean Airway Pressure Mean Airway Pressure display on the 3100B HFOV OI Oxygenation Index: (mpaw x FiO 2 x 100)/PaO 2 P/F ratio PaO 2 / FiO 2 PIP Peak Inspiratory Pressure 43

48 References 1 Derdak S., Mehta S., et al. High Frequency Oscillatory Ventilation for Acute Respiratory Distress Syndrome in Adults: A Randomized, Controlled Trial. Am J Respiratory Critical Care Medicine, 2002; 166: Ferguson N., Chiche J., et al. Combining High-Frequency Oscillatory Ventilation and Recruitment Maneuvers in Adults with Early Acute Respiratory Distress Syndrome. The Treatment with Oscillation and Open Lung Strategy (TOOLS) pilot study. Critical Care Medicine, 2005; 33: Johnson J., Bachman TE. Refining and Validating a Risk Assessment Tool for HFOV Rescue of ARDS Patients. Reparatory Therapy, 2006; 2: