Policy & Procedure Ino Without Hosp Id Info

Inhaled Nitric Oxide Policy and Procedure

1. DESCRIPTION: Inhaled nitric oxide (INO) is a potent pulmonary vasodilator that, when delivered via the INOvent®, may reduce pulmonary artery pressure and pulmonary vascular resistance. Improved oxygenation may also occur upon reversal of hypoxia-induced pulmonary vasoconstriction.

2. ORDERING PRIVILEDGES: The XX Hospital & Clinics Pharmacy and Therapeutics Committee approved INO for off-label use for adult patients with the mandate that a consultation with Dr. Ronald Pearl precede all requests for an INO trial. The acting ICU attending should be consulted if Dr. XX is not available.

3. INDICATIONS: A. Intraoperative

a. Pulmonary hypertension and/or severe graft dysfunction post heart/heart-lung transplantation.b. Pulmonary hypertension complicating removal from cardiopulmonary bypass.

B. Postoperativea. Continuance of intraoperative benefits

C. Severe/refractory hypoxemia during mechanical ventilationINO may reduce pulmonary hypertension and increase oxygenation for patients with ARDS or ALI. NOTE: Controlled studies failed to demonstrate a sustained improvement in oxygenation or improvement in mortality with INO therapy for patients with ARDS.

D. Non-invasive (mask) Diagnostic INO trialsAs a selective pulmonary vasodilator, INO appears to be an accurate screening agent for a pulmonary vasodilator response to other agents. Adult patients with documented, or suspected, primary pulmonary hypertension (PPH) can be evaluated for pulmonary vascular response to INO as a bedside procedure or during cardiac catheterization (see Cath Lab Protocol).

4. CONTRAINDICATIONS: 1. Elevated methemoglobin (>5.0 mg/dl)2. Pregnancy: It is not known if INO can cause fetal harm when administered to a pregnant woman.

5. INO TRIAL GUIDELINES: A. Purpose: These guidelines support the XX Hospital & Clinics Pharmacy and Therapeutics Committee

mandate for the initiation of an inhaled nitric oxide (INO) trial. The following guidelines also discourage simultaneous adjunctive measures (i.e. PEEP trials, prostacyclin administration) which may obscure the interpretation of an INO trial response..

B. Order set: An order approved by Dr. Ronald Pearl stating "INO trial per protocol" will authorize:1. An initial trial dose of 20 ppm. 2. Response criteria* after 15 minutes of administration:

-Oxygenation: an increase in PaO2 > 10% above baseline.-Hemodynamic: a 10% decrease in mean pulmonary artery pressure or 20% decrease in pulmonary vascular resistance.

*Intraoperative response criteria will be determined by the attending surgeon

C. Titration criteria: INO should be titrated downward in 5ppm increments Q 15 minutes with assessments to maintain clinical response at the lowest concentration of INO. If a titration end-point of 5 ppm is attained, this concentration will be maintained for the first day of INO administration.

D. Discontinuation: INO administration should be discontinued if the patient fails to meet response criteria at 20 ppm.

A

BC

D

E

TRANSPORT CONFIGURATION

1. Manual INO delivery configuration: The manual delivery configuration is pneumatic; electrical power is not required and the INOvent can be OFF during transport. In combination with oxygen from the 'E' cylinder, the INOvent provides 20ppm of NO.

a. The black high-pressure (A) hose connects the 'E' cylinder regulator outlet to the Thorpe tube flowmeter inlet (B).

b. The green high-pressure hose connects the Thorpe tube flowmeter outlet (C) to the inlet (D) located on the back of the INOvent.

c. The resuscitation bag oxygen supply line connects to the NO/O2 outlet (E)

from the INOvent.

d. Upon arrival to the ICU, remove the high-pressure hose (A) from the 'E' cylinder and connect it to a wall source oxygen flowmeter or 50 psig adapter.

2. Manual INO delivery procedure:a. Configure the manual delivery system as shown above. NOTE:

Self-inflating resuscitation bags are generally preferred since the maximum flow from the INOvent is 15 LPM.

b. Turn the flowmeter (F) to flush.c. The manual flow delivery float (G) will rise to the center of the tube indicating that NO @ 20 ppm is delivered to the bag.

F

G

INO FOR DIAGNOSTIC TESTING IN THE CARDIAC CATH LAB

The protocol for diagnostic INO testing at XX Hospital & Clinics examines the efficacy of low dose INO as a pulmonary vasodilator in patients with pulmonary vascular disease. Studies have shown that patients with reactive pulmonary vessels (i.e. non-fixed pulmonary vascular resistance) have significantly better long term outcomes when compared with patients with non-reactive pulmonary vessels. In addition, it has been shown that patients who respond to vasodilators in the catheterization lab are likely to benefit from oral calcium channel blocker therapy while those without a response are not. Therefore, the presence or absence of pulmonary vascular reactivity, as determined by diagnostic INO, plays a fundamental role in determining the best treatment option for a particular patient.

After vascular access has been obtained, patients are fully heparinized and activated clotting times are monitored and maintained >200 seconds. A standard right and (when indicated) left heart catheterization is performed with the patient breathing room air. Baseline measurements of the pulmonary artery pressure, left atrial or capillary wedge pressure, aortic pressure, and right atrial pressure are recorded. Oxygen saturation will be sampled in the superior vena cava, pulmonary artery and aorta at a minimum. Direct measurement or calculation of the cardiac output is also performed.

The above pressure measurements, oxygen saturation and cardiac output determinations are repeated under the following conditions: (See attached algorithm and data collection sheet)

• 100% oxygen (infants and children only)• 5 ppm INO with room air• 20 ppm INO with room air• 20 ppm INO with 100% oxygen

Measurements are taken after INO is administered at each of the conditions for 15 minutes.

1. INOvent delivery/positioning:Diagnostic INO studies are scheduled procedures with at least 24 hours prior notice to Respiratory Care Services. The INO vent should be delivered and set-up in the cardiac cath lab at least 30 minutes before the start of the procedure. Attempting to set-up INO during the procedure is not practical and may allow contamination of the sterile equipment area. The INOvent is positioned as shown in the figure 1.

The mask-securing head strap must be placed on the procedure table before the start of the procedure. Attempting to place the strap during the procedure is complicated by the sterile field.

Figure 1.

Figure 4.

2. INOvent set-up: Before patient arrivala. After placing the INOvent in the appropriate location, plug the unit into the power strip connected to the red emergency outlet.b. Assemble the pre-packaged non-invasive circuit as shown in figure 2. Gas source (air & oxygen)

to injector module. Reservoir bag/sample line assembly to injector module outlet. Aerosol tubing from sample connection to one-way valve mask connection (figure 3).

c. Connect the labeled O2 and air supply lines to the appropriate flowmeters. NOTE: the gas

outlets are located on the far side of the fluoroscope on a ceiling-mounted unit (fig. 4).NOTE: Following the procedure, the air flowmeter must be returned with the reusable components.

d. Set the air flowmeter to an approximate flush setting.NOTE: The horizontal position of the air flowmeter prevents an accurate display of the actual set flow.

e. Turn the INOvent ON and perform a low-range calibration per established procedure.NOTE: DO NOT TURN TANK ON until INO delivery is initiated.

f. After successful completion of the low range calibration, turn the INOvent OFF. Provide your pager number to the Cath Lab staff; you will be contacted when the INO portion of the trial begins.

3. Initiation of INO trial:a. Before entering the procedure area, put on a lead gown located in the anteroom.b. Turn the INOvent ON. NOTE: If the patient requires oxygen, turn the O2 flowmeter to the setting that

provides the desired FiO2 as measured by the INOvent.c. Introduce yourself to the patient and briefly explain the purpose of the mask.d. Hold the mask to the patient's face as they adjust to the feel of the mask and flow of air. e. Secure the mask once you have determined that the patient will tolerate the closed system.f. Turn the NO cylinder ON, and purge per procedure.g. Monitor the patient and adequacy of gas flow during the entire testing period.

4. Documentation:a. Record the appropriate patient information and time on the Tank Log.b. Enter Therapist Time in Clinivision and chart accordingly.

A

B C

NOTE: The directional valves permit only INO delivery to the mask.

CAUTION: The gas source flow must be sufficient to maintain adequate inflation of the reservoir bag at all times to meet patient demand.

Figure 2.

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B

C

Figure 3.

Non-disposableEquipment

THIS FORM IS COMPLETED BY THE PHYSICIAN OR RESEARCH R.N.

THIS FORM IS COMPLETED BY THE PHYSICIAN OR RESEARCH R.N.

INO ADMINISTRATION IN THE OPERATING ROOM

INO administration in the O.R. is typically unscheduled and should be considered an urgent application.As described in section I.3.A, the intraoperative delivery of INO is most often indicated during heart or heart-lung transplantation, or other cardiac surgical procedures.

1. O.R. attire: Protective attire for entry to the O.R. region is located in SAU and includes white coveralls, shoe covers, hair cover, and mask. As a standard precaution, hand washing or alcohol gel lotion should be applied before entry; gloves are not required.

2. O.R. suite entry and INOvent placement: Confirm that INO has been requested before bringing the INOvent into the specific O.R. suite. The position of the INOvent in the room will be at the discretion of the perfusionist and anesthesiologist. Make sure that the INOvent is not wheeled over tubing connected to the patient or to OR equipment. 3. INOvent setup:

a. Plug the unit directly into a RED emergency outlet or power strip originating from a RED outlet.b. It is NOT necessary to configure the manual delivery flowmeter to a wall O2 outlet. The manual delivery

should be configured with the accompanying 'E' cylinder for transport.c. Turn the unit ON and perform a low-range calibration.d. Assist with, or instruct, proper insertion of the injector module (Figure 1) and sample line (Figure 2) into

the circle anesthesia system.

Figure 2.

Figure 1.INSP.

EXP.

2 lengths (12") of aerosol tubing attaches to the inspiratory side on the 'Y'

Sample adapter is connected to a 15-22mm multi-adapter and inserted between the 12" aerosol tubing and blue anesthesia circuit connection

4. INOvent operation during anesthesia ventilation: Circle anesthesia systems are designed to provide rebreathing of anesthetic gases while avoiding hazards of CO2 rebreathing with the inclusion of soda-lime CO2 absorber (see diagram).

a. The delivery of INO should not begin until ventilation is restarted. The anesthesiologist begins ventilation as the gradual weaning from cardiopulmonary bypass (CPB) is initiated.

b. When instructed to do so, 'Set NO' to the prescribed level.c. Closely monitor the measured values for NO and NO2.CAUTION:In conjunction with the INOvent, recirculation of gases may complicate the accurate delivery of INO. Fresh gas flows less than the patient minute volume may result in:•Higher NO2 levels due to the limited ability of the carbon dioxide absorbent to remove NO2.•Higher NO concentrations than those set due to NO recirculated through the absorber.•Reduction in O2 concentration because nitrogen is the balance gas for NO and will be present in the re-circulated gases.d. If the values for NO and/or NO2 reflect the previously described CAUTION, inform the anesthesiologist and request an increase in fresh gas flow.e. Assist in the patient transport from the OR to the ICU.

5. Documentation:a. Record the appropriate patient information and time on the Tank Log.b. Enter Therapist Time in Clinivision and chart accordingly.

Figure 2.

INO ADMINISTRATION DURING MECHANICAL VENTILATION

INO administration during mechanical ventilation is permitted following implementation of the Inhaled Nitric Oxide Policy and Procedure 'Ordering Privileges' and 'Indications' guidelines. An order must be written before the INO trial can begin. Administration of INO should be through the Dräger Evita 2 dura or E4 ventilator.

a. Insert the injector module directly onto the ventilator (inspiratory) outlet before the humidifier (fig. 1).

b. Cut the inspiratory limb 2 lengths from the 'Y' to insert the sample line with the 15-22mm multi

adapter (fig. 2).

c. Perform a low-range calibration.d. Open the INO cylinder and purge per procedure.e. Convert the bedside resuscitation bag to the manual delivery outlet on the INOvent.f. Scavenge exhaled gas for INO > 10ppm. (fig. 3)g. If the patient demonstrates a positive response to response to INO, convert to heated humidification

within the first hour of administration.

Figure 1.

Figure 3.Open scavenging

set-up

1 length of aerosol tubing attaches to expiratory flow sensor

Pressure line adapter is inserted midway through the tubing with a multi adapter

Suction line connects to ventilator-mounted suction canister. Vacuum is set ~60-90 mmHg

h. Enter Therapist Time in Clinivision and chart accordingly.i. Create a 'Nitric Oxide' row in CareVue and enter the initial INO value at the appropriate start time.j. Record the appropriate patient information and time on the Tank Log.