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Respiratory Therapy

Policy, Procedure & Protocol | |

AERoSOLIZED FLOLAN® ________________________________________________________________________________________

|NO.: |RTRX-5.11 |DATE ISSUED: |2009 (Draft) |

|SOURCE: |Respiratory Therapy TOH |DATE REVISED: |February 23, 2012 |

|SECTION: |Administration of medication |

|APPROVED BY: |RT Executive Committee |

| | |

INFECTION CONTROL: This is a high risk procedure. It generates droplets, exposing staff to respiratory pathogens. The appropriate level of Personal Protective Equipment (PPE) must be worn to reduce exposure.

POLICY STATEMENT:

Selective pulmonary vasodilators (iNO, Flolan® can be given when reversible pulmonary hypertension unresolved by optimal medical care results in severe cardio pulmonary compromise. They are usually administered by inhalation.

Aerosolized Flolan® therapy (PGI2) is considered to be a cost effective alternative for inhaled nitric oxide (NO) therapy. Both agents act as selective pulmonary vasodilators, improving perfusion to ventilated areas of the lungs and resulting in:

• improved ventilation/perfusion matching,

• decreased hypoxemia,

• reduced pulmonary artery pressure

• improving right heart function

• inhibition of platelet aggregation.

Aerosolized Flolan® therapy has not been conclusively proven to improve outcomes. However given that it has strong physiologic properties, a trial of this therapy may be warranted in the following areas.

1. Acute, Reversible Pulmonary Hypertension

2. Right Ventricular Failure.

This therapy is available in Critical Care areas only and should be used preferentially over iNO therapy whenever possible

Flolan therapy will ONLY be initiated once an order from a staff physician or ICU Fellow has been obtained. A pre-printed order form is available.

Refer to list of relative and absolute contraindications before initiating aerosolized Flolan® therapy. (Appendix A)

DEFINITIONS:

Flolan® Epoprostenol sodium, also known as prostacyclin, or PGI2.

Used by inhalation to cause selective pulmonary vasodilatation.

Available in the injectable form, is one strength of 1.5 mg.

Can be used for children > 10 kg and adults.

iNO Colorless, toxic, nonflammable gas used by inhalation to cause selective pulmonary vasodilatation.

ALERTS:

Aerosolized Flolan® should NEVER be used in patients with severe left ventricular systolic dysfunction, (often presenting as pulmonary edema).

Avoid aerosolized Flolan® during active pulmonary haemorrhage. Bleeding is a potential adverse effect although it has not been reported with the dose range of 5 to 50 ng/kg/minute. While IV Flolan® profoundly inhibits platelet aggregation there has been no documented increase in peri operative bleeding with inhaled use, even after cardiopulmonary bypass.

Systemic hypotension is a potential adverse effect although it has not been reported with the dose range of 5 to 50 ng/kg/minute.

Abrupt and complete discontinuation of aerosolized Flolan® must be avoided. Within 10 minutes, it may cause acute deterioration in oxygenation. Within 20-25 minutes, it may cause a rebound pulmonary vasoconstriction, acute V/Q mismatch, hypoxemia, pulmonary hypertension, and right ventricular failure.

Wean Flolan ® slowly to help reduce the potential for rebound.

Reconstituted Flolan® has a very alkaline pH (10.2-10.8) that may act as an irritant when inhaled. Care must be taken to prevent accidental spilling of the drug into the patient’s trachea. Caution must be exercised when administering this alkaline aerosol to patients with reactive airways disease.

When Flolan® is reconstituted the concentrated stock solution is stable for 24 hours with refrigeration before being transferred to the infusion pump. Reconstituted solution, once placed in the infusion pump, can be administered for up to 24 hours when temperature is maintained between 2-8oC (change frozen gel packs q12h) or up to 8 hours if at room temperature. Change concentrated stock solution and IV tubing from Flolan® bottle every 24 hours. Flolan ® is photosensitive. Protect from light.

Ventilation parameters (Expired minute volume, ventilator pressures, patient-initiated triggering, FiO2) and heated humidifier settings will vary due to the nebulizer flow into the circuit. Adjust ventilator alarm settings accordingly.

The sterile diluents for Flolan® makes the aerosol sticky. Expiratory valves and mushroom valves (HFO) may stick, resulting in increased ventilation pressures. Expiratory filters on ventilators must be changed at least every 4 hours to prevent sticking of the valves and auto-PEEP.

On anesthetic gas machine, place filters on the expiratory limb of the circuit, before the soda lime canister.

Do not administer aerosolized Flolan® during HFO. Filtering of exhaled gases at the mushroom valves is compromised. .

Monitor the volume in the nebulizer reservoir to detect when the volume emitted from the nebulizer is higher or lower than the fill rate from the infusion pumps. Make small incremental changes (+ 0.25 L/min) in oxygen flow when necessary. If nebulizer overfill is detected, or nebulizer output is insufficient despite adjusting the flow to maximum, temporarily suspend nebulizer filling by turning off the infusion pump until the problem is resolved.

The Flolan® nebulizer can be added to the manual resuscitator with filter set up for use during manual ventilation. Ensure adequate functioning of expiratory valve on manual resuscitator and change manual resuscitator filter after use.

EQUIPMENT:

2 Medication added label (SPD # 450200)

UV bag

1.5 mg vial of Flolan ® (epoprostenol sodium for injection) (Obtain from Pharmacy)

50 ml bottle of Sterile Diluent for Flolan® (Obtain from Pharmacy)

1 Primary I.V. Plum administration set tubing (outside purchase)

10 ml syringe (SPD # 140515)

18 gauge blunt needle (SPD # 150645)

Trach tie

2 labels - IV line changed

Abbott Plum A+ infusion pump

1 Secondary medication I.V. set tubing (SPD # 122070)

500 ml bag of normal saline NaCl 0.9% (SPD# 102050)

Low-flow jet nebulizer (miniHEART) (outside purchase)

2 alcohol swabs

Ice pack (SPD # 270090)

Tape (Waterproof)

1 interlink injection Adapter (SPD # 120660)

1 Lever lock cannula (SPD # 120595)

Corrugated aerosol tubing (6” length X1 and 12” length x1) (SPD # 336715)

T piece (SPD # 336995)

Oxygen tubing (SPD # 336960)

Bacterial/viral filters x2 for ventilator circuit (SPD # 733185)

PROCEDURE:

Prior to initiation of selective pulmonary vasodilator (Flolan®):

1. Expect physician to ensure ventilation is optimized:

• Review recent chest x-ray.

• Attempt ‘’open lung ventilation’’

• FIO2 >.90

• Consider placing patient in prone position

• Consider HFO or APRV

2. Expect physician to optimize perfusion:

• Ensure arterial and venous lines are in place.

• Ensure adequate pre-load /circulating volume

• Optimize hemoglobin

• Continuously monitor BP.

3. Expect physician to optimize sedation

4. Physician may consider and request adjunctive therapies. (Prostacyclin, Magnesium, Adenosine)

5. If use of inhaled selective pulmonary vasodilator is indicated, obtain arterial blood gas to establish baseline.

• Document available and pertinent hemodynamic parameters.

• Obtain a medical order from staff physician or ICU fellow. Use pre-printed orders

Initiation of Flolan®

6. Make 2 labels with “Medication Added” for the concentrated Flolan ® stock solution. Indicate concentration, date and time of dilution.

7. Prepare 2 labels with “IV line changed”. Indicate time and date tubing changed due.

8. Check expiration dates, name of medication and concentration on Flolan® vial and Flolan® diluent vial.

(Use only the sterile diluent for Flolan ® provided for reconstitution of Flolan ®)

9. Reconstitute Flolan®:

• Withdraw approximately 10 ml of the sterile diluent for Flolan ® into a sterile 10 ml syringe, inject the contents of the syringe slowly into the vial containing the Flolan ® and shake gently until the powder is dissolved.

• Draw up the resulting Flolan ® solution into the syringe and slowly re-inject it into the remaining volume of the sterile diluent for Flolan ®. Mix gently and thoroughly.

| |

|The resulting mix is referred to as the concentrated stock solution. This solution contains 30,000 ng/mL of Flolan ®. |

10. Put one label on the stock solution Flolan® bottle and the other one on the UV bag. Place stock solution bottle of Flolan® on ice pack.

| |

|Reconstituted solution, once placed in the infusion pump, can be administered for up to 24 hours when temperature is maintained between 2-8oC (change |

|frozen gel packs q12h) or up to 8 hours if at room temperature. |

11. Setup infusion Abbott Plum XL pump primary infusion (channel A) set with Flolan stock solution as per Appendix C

12. Verify expiration date, solution name and concentration on 500 ml bag of NaCl 0.9%.

13. Setup secondary infusion (channel B) with normal saline as per Appendix C.

14. Perform pump test as per Appendix C.

15. Determine predicted body weight using Table 1.

| | | | | |

| | | | | |

| | | | | |

|Table 1 | | | | |

| | | | | |

| | | | | |

| | | | | |

|Predicted Body Weight Chart for Adults | | | | |

| | | | |FEMALE | |

| | | | | | |

|MALE | | | | | |

|Male 50+0.91*(HEIGHT in cm-152.4) | | | | |

|Female 45.5+2.3*(HEIGHT in inches-60) | | | | |

|Female 45.5+0.91*(HEIGHT| | | |

|in cm-152.4) | | | |

| | |(body weight x Flolan dose) x 60 min] / PGI2 concentration |(neb output – Flolan infusion rate) |

|40 |10 |0.8 |7.2 |

| |30 |2.4 |5.6 |

| |50 |4.0 |4.0 |

|50 |10 |1.0 |7.0 |

| |30 |3.0 |5.0 |

| |50 |5.0 |3.0 |

|60 |10 |1.2 |6.8 |

| |30 |3.6 |4.4 |

| |50 |6.0 |2.0 |

|70 |10 |1.4 |6.6 |

| |30 |4.2 |3.8 |

| |50 |7.0 |1.0 |

|80 |10 |1.6 |6.4 |

| |30 |4.8 |3.2 |

| |50 |8.0 |0.0 |

|90 |10 |1.8 |6.2 |

| |30 |5.4 |2.6 |

| |50 |- |- |

|100 |10 |2.0 |6.0 |

| |30 |6.0 |2.0 |

| |50 |- |- |

17. Using a 10 ml syringe, withdraw correct amount of saline and concentrated Flolan® stock solution to obtain required dose and add to nebulizer. The total volume should equal 8 ml.

| |

|The nebulizer must contain 8 ml of solution at all times to maintain the ordered dose. |

| |

|The volume in the nebulizer acts as a safety mechanism to maintain a one hour supply of drug solution in the |

|nebulizer in case of unforeseen problems with infusion pump function or drug acquisition. |

|. |

18. Cover Flolan stock solution® with ice pack. Cover from light with the UV bag. Tape the bag in place above drip chamber vent with waterproof tape.

19. Program IV pumps as per Appendix D. Set pump to the determined infusion rate for each Flolan ® (A) and N/S (B). Make sure B is in CONCURRENT MODE.

20. Confirm infusion rates (A for Flolan, B for Normal Saline)

21. When ready for therapy, START (green hard key). Select ▲ Start All - The 2 green light above A & B should flash.

22. Prime remaining IV tubing by setting both channels (Flolan® and Normal Saline) to 10 times the normal rates. Watch tubing. Once tubing is primed return rates to previous set dose.

23. Connect the interlink injection adapter on the miniHEART nebulizer.

24. Connect 6 inch corrugated aerosol tubing from the nebulizer to the aerosol T-piece and place the T-piece inline on the inspiratory limb of the ventilator circuit.

25. Place the 12 inch corrugated aerosol tubing in the inspiratory line of the ventilator circuit between the T-piece of the micro nebulizer and the wye to serve as a reservoir and improve drug delivery. (See below)

26. Connect a lever lock cannula adapter to the end of the IV tubing.

27. Attach IV tubing to interlink injection adapter on the nebulizer.

28. Ensure there are two consecutive filters in place on the expiratory limb of the ventilator circuit. Change the filter proximal to the patient at least Q4H.

29. Ensure nebulizer is always stabilized in the upright position. Accidental spillage of the nebulizer contents into the ventilator circuit MUST be avoided.

30. Connect oxygen tubing to nebulizer and oxygen flowmeter.

31. Set oxygen flowmeter to 2 L/min. Hang “Flolan in Use” sign on flowmeter..

32. Confirm infusions rates on pump once again. They should add up to 8 ml.

33. Assess patient for response to therapy. The patient should respond within 1 hour of initiation. Obtain arterial blood gas 60 minutes after therapy has been instituted. For unfavorable response, discontinue therapy immediately.

|Assessment of Response |

| | |

|Full response |PaO2 increase > 20mmHg after 60 minutes |

| |15% decrease in mean pulmonary artery pressures |

| |15% increase in cardiac output |

| | |

|No Response |PaO2 increase of < 10mmHg after 60 minutes |

| |Little to no decrease in mean pulmonary artery pressures |

| |Little to no increase in cardiac output |

| | |

|Unfavorable response |SpO2 falls below 88% for more than 5 minutes, or |

| |15% increase from baseline of mean pulmonary artery pressure |

| |15% decrease in cardiac output or cardiac index |

| |Decrease in mean arterial blood pressure |

Weaning for Non-Responders:

34. If there is no response to therapy after 60 minutes, notify physician and initiate discontinuation of the therapy.

35. Weaning the concentration every hour. Discontinue therapy after 2 hours after minimum dose of 10 ng/kg/min has been set.

Weaning for Responders:

36. Leave all responders at maximal dose. Attempt to wean FIO2 to 0.60 while maintaining SpO2 is > 88%.

37. Once FIO2 is below 0.60, attempt to wean the Flolan® to the next lower dose Q6H, as long as no unfavorable responses are observed and SpO2 remains above 88% with an FIO2 below 0.60.

38. Return to previous dose if unfavorable response is observed. Wait 6 hours to resume weaning.

39. Notify attending physician of all negative responses or patient deterioration.

40. Once Flolan® is set to minimal dose of 10 ng/kg/min and patient as tolerated this dose for 6 hours, notify the attending physician and discuss trial of discontinuation of Flolan®.

|Spontaneously breathing patients can also receive aerosolized Flolan® therapy. Instead of placing nebulizer on inspiratory limb of ventilator circuit, place in |

|line with an aerosol mask kit. Ensure nebulizer is kept in an upright position. |

DOCUMENTATION:

1. Document on the medication administration record (MAR):

• Date and time

• Drug dose

• Route of administration.

2. Document in the Integrated Progress Notes:

• Full patient assessments, including response to therapy and weaning.

• Any complications observed and action taken

• Date & time physician notified (if applicable).

3. In the Respiratory Therapy flowsheet:

• Ventilation parameters and concurrent patient assessments, Q2H (FIO2, SpO2, CO, PAP, PVR, mean BP)

• Dose infused, Q2H

• Change of expiratory filter Q4H and PRN.

REFERENCES:

Dahlem, P., van Aalderen, W. M. C., de Neef, M., Dijkgraaf, M. G. W., & Box, A. P. (2004). Randomized controlled trial of aerosolized prostacyclin therapy in children with acute lung injury. Critical Care Medicine, 32(4), 1055-1069.

De Wet, C. J., Affleck, D. G., Jacobsohn, E., Avidan, M. S., Tymkew, H., Hill, L. L., Zanaboni, P. B., Moazami, N., & Smith, J. R. (2004). Inhaled prostacyclin is safe, effective, and affordable in patients with pulmonary hypertension, right heart dysfunction, and refractory hypoxemia after cardiothoracic surgery. The Journal of Thoracic and Cardiovascular Surgery 127(4), 1058-1067.

Hache, M., Denault, A. Y., Belisle, S., Couture, P., Babin, D., Tetrault, F., & Guimond, J. G. (2001). Inhaled prostacyclin is an effective addition to the treatment of pulmonary hypertension and hypoxia in the operating room and intensive care unit. Canadian Journal of Anesthesia 48(9), 924-929.

Haraldsson, A., Kieler-Jensen, N., Nathorst-Westfelt, U., Bergh, C. H., & Ricksten, S. E. (1998). Comparison of inhaled nitric oxide and inhaled aerosolized prostacyclin in the evaluation of heart transplant candidates with elevated pulmonary vascular resistance. Chest, 114(3), 780-786.

Kingston General Hospital, Respiratory Therapy Services, Aerosolized Prostacyclin, Number: 2-220, Revised: 2008/03

Lowson, S., M. (2005). Inhaled alternatives to nitric oxide. Critical Care Medicine, 33(3), S188-S195.

Lowson, S., Doctor, A., Walsh, B. K., & Doorley, P. A. (2002). Inhaled prostacyclin for the treatment of pulmonary hypertension after cardiac surgery. Critical Care Medicine 30(12), 2762-2764.

Mebazaa, Al, Karpati, P., Renaud, E., & Algotsson, L. (2004). Acute right ventricular failure – from pathophysiology to new treatments. Intensive Care Medicine, 30, 185-196.

Rimensberger, P. C., Spahr-Schopfer, I., Berner, M., Jaeggi, E., Kalangos, A., Friedli, B., & Beghetti, M. (2001). Inhaled nitric oxide versus aerosolized iloprost in secondary pulmonary hypertension in children with congenital heart disease. Circulation, 544-548.

Siobal, M. (2004). Aerosolized prostacyclins. Respiratory Care 49(6), 640-652.

Siobal, M. S., Kallet, R. H., Pittet, J. F., Warnecke, E. L., Kraemer, R. W., Venkayya, R. V., & Tang, J. F. (2003). Description and evaluation of a delivery system for aerosolized prostacyclin. Respiratory Care 48(8), 742-753.

Stuart, L., Doctor, A., Walsh, B. K., & Doorley, P. A. (2002). Inhaled prostacyclin for the treatment of pulmonary hypertension after cardiac surgery. Critical Care Medicine 30 (12), 2762-2764.

Theodoraki, K., Rellia, P., Thanopoulos, A., Tsourelis, L., Zarkalis, D., Sfyrakis, P., & Antoniou, T. (2002). Inhaled iloprost controls pulmonary hypertension after cardiopulmonary bypass. Canadian Journal of Anesthesia 49(9), 963-967.

Van Heerden, P.V. , Barden, A., Michalopoulos, N., Bulsara, M.K., Roberts, B.L. (2000) Dose-Response to Inhaled Aerosolized Prostacyclin for Hypoxemia Due to ARDS. Chest 117:819-827.

Appendix A: Absolute and Relative Contra Indications to aerosolized Flolan® Therapy.

|Absolute Contraindication |Relative Contraindication |

| | |

|Severe left ventricular systolic dysfunction |Active pulmonary hemorrhage |

|(frequently presenting as pulmonary edema) | |

| | |

|Patients on High Frequency Oscillation |Reactive airway disease |

|(filtering, stickiness of solution) | |

Appendix B: Decision tree for aerosolized Flolan® Therapy.

[pic]

Appendix C: Setting up the Abbott Plum XL pump.

1. Prepare the Flolan using the Primary I.V. Plum administration set:

Close the upper clamp on the administration set.

Push in the flow regulator on the cassette to close it.

Expose the outlet of the IV container and insert the connector from the drip chamber into the outlet with a twisting motion.

For the diluted Flolan bottle, remember to open the vent port above the drip chamber.

Fill the drip chamber to the score mark.

Hang Flolan bottle on IV pole.

To prime the cassette, open the clamp above the drip chamber.

Turn open the flow regulator on the cassette.

Invert the cassette.

Once a drop of fluid is seen in the pumping chamber, turn the cassette upright. Prime the tubing slightly beyond cassette ONLY.

Do NOT prime the remainder of the administration set.

Push in the flow regulator to close it.

Confirm that there is no flow.

To load the cassette into the IV pump, open the cassette door by lifting the door handle.

Holding the cassette by its finger grip, slide it into the cassette door guide until it firmly seats in the door. Close the cassette door with handle.

Attach completed label “IV tubing changed” to the primary IV tubing.

2. Prepare the Normal Saline using the Secondary Medication I.V. administration set:

Close the clamp on the administration set.

Insert the connector from the drip chamber into the instillation port of the IV bag of Normal Saline.

Fill the drip chamber to the score mark.

Hang bag of Normal Saline bottle on IV pole.

Open clamp and prime remainder of tubing, flushing out all air.

Close clamp and confirm that there is no flow.

Remove luer lock cap from cassette and connect the secondary I.V. tubing of normal saline to the cassette (A) of the Flolan infusion pump. Open clamp on secondary IV set.

NB The secondary I.V. set will dose concurrently. ((B) on the Pump A+)

3. Perform IV pump test.

Turn on the pump

After the pump completes initialization and cassette test with no alarm, do the following:

 

• Open the pump door lever

• Pinch tubing proximally (2-4 inches above the cassette)

• With the tubing still pinched, close the door lever and let the infuser initialize. This should generate an audible alarm.

• If the audible alarm does not sound, remove the pump from service, send to biomed and notify a manager.

• If the audible alarm does sound, silence the alarm, open the door, eliminate the occlusion, close the door and let the device complete the cassette test. 

• Continue to use the device normally after the cassette test is complete.

 

Note:  Do not perform test while the pump is being used on a patient.

Appendix D: Programming the IV Pump

Press ON/OFF to turn unit on.

If “Clear Settings?” message appears – Press ▲ Yes.

Main Delivery screen will appear.

To Program a delivery rate for Flolan, select ▲A

To enter delivery rate, use numeric key pad.

Set to required Flolan rate determined from Table 2.

Use the Select ▼ on the numeric key pad to go to VTBI.

Calculate volume of Flolan to be infused:

Flolan bottle 50 ml

Priming of IV tubing – 20 ml

Dose in nebulizer (from Table 2) – X ml

Use the numeric key pad to set the Volume to be infused (VTBI).

Select ▲ Program Options, press ▲Standby, press ▲YES.

To Program a delivery rate for the Normal Saline, select ▲ B

Press ▲Change mode to change from Piggyback to CONCURRENT.

Use the Select ▼ on the numeric key pad and set rate for Normal Saline as

determined from Table 2 using numeric keypad.

Use the Select ▼ on the numeric key pad to go to VTBI.

Calculate volume of Normal Saline to be infused:

250 ml – 7 ml – set dose of normal saline (from Table 2)

Select ▲ Program Options and press ▲Standby

You will have 2 indicator lights above A and B steady green indicating set up

is complete but not activated.

-----------------------

[pic]

Start Flolan at maximal dose of 50nk/kg/min

Optimize current medical care:

• Ventilation optimized

• Perfusion optimized

• Sedation optimized

Selective pulmonary vasodilator still indicated?

YES

NO

Continue with current therapy

Assess patient response after 60 minutes

Full response

No response

Unfavourable response

Notify physician

Discontinue Flolan therapy

Notify physician

Wean Flolan therapy and discontinue within 6 hours

Remain at current dose until FIO2 can be weaned to less than 0.60 with SpO2 -¬[pic]Œ¬[pic]î¬[pic]ð¬[pic]b­[pic]d­[pic]¾­[pic]À­[pic].®[pic]O®[pic]P®[pic]R®[pic]S®[pic]U®[pic]V®[pic]X®[pic]Y®[pic][®[pic]\®[pic]l®[pic]¸®[pic]1¯[pic]2¯[pic]3¯[pic]G¯[pic]ööééäääÛÛÛÙÙÙÙÙÙ≥ 88%.

Wean dose of Flolan to next step every 6 hours as tolerated.

Notify physician if weaning is not tolerated and return to previous dose for another 6 hours.

Once patient has tolerated minimum Flolan dose for 6 hours, notify physician and consider trial of discontinuation.

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