SCVMC RESPIRATORY CARE PROCEDURE

Transcription

1 Page 1 of 7 New: 12/08 R: 4/11 R NC: 7/11, 7/12 B Definitions: Inhaled nitric oxide (i) is a medical gas with selective pulmonary vasodilator properties. Vaso-reactivity is the evidence of acute vasodilation to a pharmacologic agent. The FDA Approved label for Imax brand of inhaled nitric oxide reads as follows: Imax, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation. Inhaled nitric oxide (i) is a selective pulmonary vasodilator approved by the FDA. Neonatal and Nonneonatal use of nitric oxide will be governed by this policy to ensure appropriate and safe administration of inhaled nitric oxide and has been used in these populations for on and off label usage and investigative purposes in the treatment of the following possible indications: Guidelines: These guidelines are to help the practitioner: 1. Use i in the appropriate class indication 2. Establish the efficacy and effectiveness of i therapy as quickly as possible. 3. Wean i therapy as quickly and as safely as possible. 4. Safely discontinue the therapy when indicated. Class Indicators: 1. Class I. Documented Efficacy in Clinical Trials Use of Nitric Oxide () is Unrestricted with these indicators a. Neonatal Hypoxic Respiratory Failure b. Neonates with documented Persistent Pulmonary Hypertension of the Newborn (PPHN) 1. Echocardiographic evidence 2. Clinical evidence 2. Class II. Probable Efficacy--Use restricted to those patients showing documented improvement of elevated PAP or improved Pulmonary blood flow or CVP on ECHO or Pulmonary Artery line a. Infant and Pediatric patients with Pulmonary HTN b. Infant and Pediatric patients with Single Ventricle palliation and elevated PVR

2 Page 2 of 7 New: 12/08 R: 4/11 R NC: 7/11, 7/12 B Class III. Possible Efficacy Use of restricted to trial therapy. Must be a documented positive effect within ¾ hour of initiation. Improved PAP, and/or increased cardiac output, and/or improved oxygenation and/or oxygen saturation shall be considered positive effect for these indications. a. Cardiac surgery complicated by Pulmonary Arterial Hypertension (PAH) and RV dysfunction. b. RV failure due to acute MI or Pulmonary Embolism. c. Heart Transplant patients with elevated PAP and/or RV dysfunction. d. RV failure post insertion of a left ventricular assist device (LVAD). e. Treatment of pulmonary ischemia-reperfusion injury following lung transplantation. 4. Class IV. Unknown Efficacy -- Use of restricted to short trial of therapy for immediate lifethreatening condition. Continued use only with documented Improved PAP, Improved MAP, and/or increased C.O. /C.I., and/or improved oxygenation and/or oxygen saturation. a. Acute Respiratory Distress Syndrome (ARDS). General Information Nitric oxide () is normally produced by the blood vessels in all parts of the body to cause smooth muscle dilation by reacting with guanylate cyclase, an enzyme already resident in the smooth muscle, promoting the formation of cgmp. The increase in levels of cgmp leads to smooth muscle relaxation. This reduces blood pressure in the affected vessels. When nitric oxide is inhaled, it acts locally to dilate pulmonary blood vessels. Its half-life is 3-5 seconds and it becomes rapidly bonded and inactivated by hemoglobin, forming methemoglobin. Nitric oxide has no measurable effect on systemic circulation. 1. Studies have demonstrated that there is likely no significant difference between epoprostenol and nitric oxide (regarding improvement in oxygenation, pulmonary hypertension, and right heart dysfunction), but there is a significant cost difference. Controlled use of inhaled nitric oxide in the adult population may be beneficial for the treatment of pulmonary hypertension with or without right heart failure, and hypoxemia. 2. Dosage: The concentrations of nitric oxide most commonly used are PPM, with 80 PPM the maximum dosage allowable. Any benefit from inhaled nitric oxide administration occurs rapidly (within 5-30 minutes). Please note that improvement in oxygenation most likely occurs at much lower doses (i.e., 10 PPM or less). 3. Hazards of Administration A. Normal body levels of methemoglobin are 0-2%. Nitric oxide binds with hemoglobin to form methemoglobin (MetHb), a form of hemoglobin that cannot carry oxygen. Therefore, an increase of MetHb in the blood causes a decrease in oxygen delivery. MetHb levels should be monitored routinely. MetHb levels should remain < 5%. 1. An ABG should be drawn, for both adults and infants, initially and then Q Shift (12 hrs) x 24 hrs then monitored Q Day. a. If there is a worsening MetHb, from baseline, monitor Q Shift. b. Monitor worsening MetHb until stabilized or improved to levels < 5% then monitor Q Day.

3 Page 3 of 7 New: 12/08 R: 4/11 R NC: 7/11, 7/12 B B. Nitric oxide reacts chemically with O 2 to form nitrogen dioxide ( 2 ). Nitrogen dioxide is a toxic irritant to the lung. Occupational Health and Safety Administration (OSHA) guidelines limit 2 exposure to 5 PPM (continuous exposure over an 8-hour period). C. Exposure to inhaled nitric oxide may also produce physiological effects, including chest tightness, headache, eye irritation, nausea, and loss of strength. OSHA guidelines limit inhaled nitric oxide exposure to 25 PPM (continuous exposure over an 8-hour period). D. Animal (feline) models suggest systemic effects including vascular smooth muscle relaxation, impaired leukocyte adhesion, impaired inflammatory response, increased vascular leak, and impaired platelet adhesion 7. ***TE*** Patients who respond to I as indicated by an increase in PaO2 or a decrease in systolic PA pressure should not be abruptly discontinued due to the risk of rebound effect (increase in PAP or worsening oxygenation.) Patients who do not demonstrate an initial response to I are less likely to develop rebound and may tolerate rapid I withdrawal and discontinuation when it is determined to be of no therapeutic benefit. Patient Evaluation: Only patients in the intensive care units and/or cath lab are eligible for Nitric Oxide treatment. Exclusion Criteria/Protocol Exception: 1. The only patients that will be excluded from this protocol will be patients being administered Nitric Oxide for diagnostic purposes in the Cath lab and patients receiving Nitric Oxide in the OR during a surgery procedure. Procedure/Protocol (Pre-setup Assessment/Monitoring) 1. Set up, delivery method and calibrations will be in accordance to manufacturer s recommendations 2. Prior to initiation of, for monitoring purposes, consider placement of a central line/ PA catheter, arterial line or the NICO (Non Invasive Cardiac Output) monitor. A. Hemodynamic/respiratory monitoring parameters may include, but are not limited to the following: 1. Blood Pressure/Heart Rate/Urine Output response 2. Central Venous Pressure (CVP), Pulmonary Arterial Pressure (PAP), Cardiac Output (CO), Cardiac Index (CI), Pulmonary Vascular Resistance (PVR) 3. Oxygenation, Mean Airway Pressure (MAP) 3. RCP to Assess and document the following: A. For an oxygenation condition: 1. PaO2 2. SaO2 3. PaO2 / FiO2 ratio

4 Page 4 of 7 New: 12/08 R: 4/11 R NC: 7/11, 7/12 B B. For any other patient condition: 1. Mean pulmonary artery pressures 2. Pulmonary vascular resistance 3. Cardiac index / Cardiac Output 4. Start Nitric Oxide at 20 ppm. (Procedure/Protocol) A. After 45 minutes at 20 ppm, is there improvement in: For an oxygenation condition: For any other patient condition: a. > 10% PaO2 a. > 15% decrease in mean pulmonary artery pressures b. > 10% SaO2 b. > 30% decrease in pulmonary vascular resistance c. > 10% increase in PaO2 / FiO2 ratio c. > 10% increase in cardiac index 5. If there is no change or less then indicated change, increase to 40 ppm. After 15 minutes at 40 ppm, if there is still no change in parameters, notify physician for possible discontinuation of nitric oxide. 6. If there is the indicated change in listed parameters, decrease to 30 ppm and wait minutes. A. After minutes at 30 ppm is there improvement in: 1. For an oxygenation condition: a. > 10% PaO2 b. > 10% SaO2 c. > 10% increase in PaO2 / FiO2 ratio 2. For any other patient condition: a. > 15% decrease in mean pulmonary artery pressures b. > 30% decrease in pulmonary vascular resistance c. > 10% increase in cardiac index 7. If there no change or less indicated, with at 30 ppm, increase back to 40 ppm and continue evaluation at least every 4 hours until able to wean to DC. 8. If there is the indicated change in listed parameters, decrease to 20 ppm and wait minutes. Pick up i protocol at #4, page 4 of this protocol as below: (Start Nitric Oxide at 20 ppm. After minutes at 20 ppm, is there improvement in :) A. For an oxygenation condition: 1. > 10% PaO2 2. > 10% SaO2 3. > 10% increase in PaO2 / FiO2 ratio B. For any other patient condition: 1. > 15% decrease in mean pulmonary artery pressures 2. > 30% decrease in pulmonary vascular resistance 3. > 10% increase in cardiac index Section 4, Page 4 of i Protocol

5 Page 5 of 7 New: 12/08 R: 4/11 R NC: 7/11, 7/12 B If there is the indicated change in listed parameters at 20 ppm, decrease to 10ppm and wait minutes. A. After minutes at 10 ppm is there a sustained improvement in: 1. For an oxygenation condition: a. > 10% PaO2 b. > 10% SaO2 c. > 10% increase in PaO2 / FiO2 ratio 2. For any other patient condition: a. > 15% decrease in mean pulmonary artery pressures b. > 30% decrease in pulmonary vascular resistance c. > 10% increase in cardiac index 10. If there no change or less than 10%, with at 10 ppm, increase back to 20 ppm and continue evaluation at least every 4 hours until able to wean to DC. 11. If there is an indicated change, decrease to 5 ppm and wait for 15 minutes. A. After minutes at 5 ppm, is there a sustained improvement in: 1. For an oxygenation condition: a. > 10% PaO2 b. > 10% SaO2 c. > 10% increase in PaO2 / FiO2 ratio 2. For any other patient condition: a. > 15% decrease in mean pulmonary artery pressures b. > 30% decrease in pulmonary vascular resistance c. > 10% increase in cardiac index 12. If there is a positive change, leave at 5 ppm and attempt to wean to DC at least every four (4) hours. 13. If there no change or less than indicated change, with at 5ppm, increase back to 10 ppm and continue evaluation at least every 4 hours until able to DC. Monitoring the Patient s Response to Therapy 1. A positive response is defined as a CLINICALLY MEANINGFUL improvement in oxygenation, pulmonary artery pressures, and/or right heart function. This should be assessed per departmental policy after commencement of therapy. If clinically meaningful improvement has not occurred then the therapy should be weaned and/or discontinued as indicated. A positive response is: A. > 15% decrease in mean pulmonary artery pressures B. > 30% decrease in pulmonary vascular resistance C. > 10% increase in cardiac index D. > 10% increase in PaO 2 / FiO 2 ratio E. > 10% increase in PaO 2 F. > 10% increase in SaO 2 G. Nitric oxide can be weaned until the patient is stable on a dose of 5 ppm and then the nitric oxide can be discontinued.

6 Page 6 of 7 New: 12/08 R: 4/11 R NC: 7/11, 7/12 B REFERENCES: Protocols: 1. North Carolina Baptist Hospital, Respiratory Care Policy/Procedure; Nitric Oxide Administration, PPB-NCBH-RC Tampa General Hospital, Respiratory Care Policy/Procedure; Nitric Oxide Administration Outside the Neonatal ICU 3. Barnes Jewish Hospital, Organizational Policies/Procedures; Nitric Oxide Administration Inhaled 4. Stony Brook University Medical Center, Respiratory Care Department Policy and Procedure Manual Code; Inhaled Nitric Oxide Use General References: 5. Bloch KD, Ichinose F, Roberts Jr. JD, Zapol WM. Inhaled as a therapeutic agent. Cardiovascular Research 2007; 75: Inhaled Nitric Oxide Therapy in Adults. N Engl J Med 2005; 353: Gaston B. Summary: Systemic Effects of Inhaled Nitric Oxide. Proc Am Thorac Soc 2006; 3:

7 Page 7 of 7 New: 12/08 R: 4/11 R NC: 7/11, 7/12 B Santa Clara Valley Medical Center Respiratory Care Nitric Oxide () Administration Protocol MD writes order for Nitric Oxide Therapy RCP Documents baseline parameters for: PaO2 Sp02 MAP PAP PVR Diagra Ordering Indications Class I Class II Class III Class IV B New: 10/08 Attachment A Start Nitric Oxide at 20 ppm Wait 15 minutes Increase Nitric Oxide to 40 ppm Wait 15 minutes Wean Nitric Oxide to 10 ppm Discontinue Nitric Oxide Decrease Nitric Oxide to 30 ppm Wait 15 minutes Wean Nitric Oxide to 5 ppm Return patient at 20 ppm and evaluate for weaning every 4 hours Return patient to 40 ppm and evaluate for weaning every 4 hours Return patient at 10 ppm and evaluate for weaning every 4 hours 1. Class I. Documented Efficacy in Clinical Trials Use of Nitric Oxide () is Unrestricted with these indicators a. Neonatal Hypoxic Respiratory Failure b. Neonates with documented Persistent Pulmonary Hypertension of the Neonate (PPHN) 1. Echocardiographic evidence 2. Class II. Probable to Possible Efficacy--Use restricted to those patients Showing documented improvement of elevated PAP or improved pulmonary blood Flow or CVP on ECHO or Pulmonary Artery line a. Infant and Pediatric patients with Pulmonary HTN b. Infant and Pediatric patients with Single Ventricle palliation and elevated PVR Leave patient at 5 ppm and evaluate for DC every 4 hours 3. Class III. Probable to Possible Efficacy Use restricted to trial therapy. Must be a documented positive effect within ½ hour of initiation. Improved PAP, and/or increased C.O., and/or improved oxygenation and/or oxygen Saturation shall be considered positive effect for these indications. a. Cardiac surgery complicated by Pulmonary Arterial Hypertension (PAH) and RV dysfunction. b. RV failure due to acute MI or Pulmonary Embolism. c. Heart Transplant patients with elevated PAP and/or RV dysfunction. d. RV failure post insertion of a left ventricular assist device (LVAD). e. Treatment of pulmonary ischemia-reperfusion injury following lung transplantation. PaO2 = Arterial Oxygenation Level Sp02 = Pulse Oximetry Oxygen Saturation Level MAP = Mean Arterial Pressure PAP = Mean Pulmonary Artery Pressure CI = Cardiac Index PVR = Pulmonary Vascular Resistance 4. Class IV. Unknown Efficacy -- Use restricted to short trial of therapy for immediate life-threatening condition. Continued use only with documented Improved PAP, Improved MAP, and/or increased C.O. /C.I., and/or improved oxygenation and/or oxygen saturation. a. Acute Respiratory Distress Syndrome (ARDS).