UTMB RESPIRATORY CARE SERVICES
PROCEDURE - Operating Instructions for Inhaled Nitric
Oxide Therapy With Mechanical Ventilation
Policy 7.3.57
Page 1 of 7
Operating Instructions for Inhaled Nitric Oxide Therapy With
Mechanical Ventilation
Effective:
Reviewed:
07/03
5/31/05
Formulated: 07/03
Operating Instructions for Inhaled Nitric Oxide Therapy
With Mechanical Ventilation
Purpose
To provide guidelines for the initiation of inhaled nitric oxide therapy via the
INOvent delivery system by completing the pre-use system purge and
performance test.
Audience
Physicians, Nursing staff, and Licensed Respiratory Care Practitioners.
Scope
Inhaled Nitric Oxide is a selective pulmonary vasodilator. It is supplied as a
gaseous blend of 0.8% NO and 99.2% nitrogen (N2).
Physician's
Order
Physician orders must include the following:
 Mechanical ventilation parameters
 Nitric Oxide concentration in ppm
 Methemoglobin levels prior to the initiation of therapy, every hour
times 4 hours after initiation of therapy, and at least every morning
throughout the duration of treatment.
Indications
Inhaled nitric oxide therapy is indicated in term and near-term (>34 weeks)
neonates with hypoxic respiratory failure that is associated with:
 Meconium aspiration syndrome (MAS)
 Pneumonia/ Sepsis
 Persistent Pulmonary Hypertension of the Newborn (PPHN)
 Congenital Diaphragmatic Hernia (CDH)
 Respiratory Distress Syndrome (RDS)
The use of inhalational nitric oxide for conditions associated with pulmonary
artery hypertension in the adult and pediatric patient has not been approved
by the FDA and is considered to be “off-label” use of the drug.
Goals
The goals of delivering inhaled nitric oxide are to:
 Improve and maintain oxygenation
 Reduce the need for extracorporeal membrane oxygenation (ECMO)
Relieve primary pulmonary artery hypertension
Adverse
Effects
The adverse effects associated with inhaled nitric oxide therapy include:
 Rebound (abrupt discontinuation of INO may lead to worsening
oxygenation and increasing pulmonary artery pressure)
 Methemoglobinemia (increases with dose of INO)
 Increased levels of NO2
 Inhaled nitric oxide therapy should not be used in patients that are
dependent on right-to-left shunting of blood
Continued next page
UTMB RESPIRATORY CARE SERVICES
PROCEDURE - Operating Instructions for Inhaled Nitric
Oxide Therapy With Mechanical Ventilation
Policy 7.3.57
Page 2 of 7
Operating Instructions for Inhaled Nitric Oxide Therapy With
Mechanical Ventilation
Effective:
Reviewed:
07/03
5/31/05
Formulated: 07/03
Equipment
Procedure




1 - INOvent delivery system
2 - Full NO cylinders
1 - Siemens Servo 300 or Newport Breeze mechanical ventilator
1 - Adult, pediatric, infant, or neonatal manual resuscitation bag
Refer to the appropriate equipment manual for assembly instructions.
Pre-Use System Purge and Performance Test
Step
Action
1
Turn the INOvent delivery system ON and confirm that both
the buzzer and speaker sound.
2
With the INOvent system ON, turn each cylinder valve ON
and then OFF. Check for adequate cylinder pressures. Wait
30 seconds and check for pressure decrease (indicating leak
in system)
3
Assemble Injector Module for system purge and
performance test. See Appendix I.
4
Perform low range calibration of the NO, NO2, and O2
monitors.
5
Set the oxygen flow to 15 L/min and set the NO
concentration to its maximum setting.
6
Ensure that the cylinder pressure drops and that the Low
NO/N2 pressure and Delivery Failure alarms sound.
7
Turn on the NO cylinder that will be used to initiate therapy.
8
With O2 running at 15 L/min, set the NO to 40 ppm.
9
Wait 3 minutes or until monitor readings are stable for the
following:
O2 – 95%
NO2 (max) – 1.5
NO ppm (min/max) – 32/48
Continued next page
UTMB RESPIRATORY CARE SERVICES
PROCEDURE - Operating Instructions for Inhaled Nitric
Oxide Therapy With Mechanical Ventilation
Policy 7.3.57
Page 3 of 7
Operating Instructions for Inhaled Nitric Oxide Therapy With
Mechanical Ventilation
Effective:
Reviewed:
07/03
5/31/05
Formulated: 07/03
Procedure
Continued
Manual NO Delivery System Purge and Performance Test
Step
Action
1
Connect green O2 hose (50 psi) to the flow meter outlet and
to the INOvent delivery system at the O2 inlet connector.
2
Connect the black O2 hose (50 psi) to the back of the flow
meter manifold and then to a 50-psi wall or cylinder O2
source.
3
Connect the O2 tubing from the manual resuscitator bag with
O2 reservoir to the NO/O2 output connector on the back of
the INOvent delivery system.
4
Disconnect the O2 tubing from the resuscitator bag and
connect a 15M x 4.5 mm adapter with a sample tee.
5
Attach sample line to the sample tee.
6
Turn flow meter to 15 L/min and ensure that the float moves
to the middle of the NO Flow Indicator Window.
7
Ensure that NO reading is 20 + 8 ppm and the NO2 reading
is less than 1.0 ppm.
8
Reduce O2 flow to 1 L/min. Ensure that float drops to the
bottom of the NO flow indicator.
Set O2 flow to zero and disconnect sample tee and
15 M x 4.5mm adapter from the O2 tubing. Reconnect the
resuscitator bag to the oxygen tubing.
9
2
Connect the black O2 hose (50 psi) to the back of the flow
meter manifold and then to a 50-psi wall or cylinder O2
source.
Initiation of Therapy with Conventional Mechanical Ventilation
Step
1
Action
Obtain arterial blood gas analysis of methemoglobin level
prior to the initiation of therapy.
Continued next page
UTMB RESPIRATORY CARE SERVICES
PROCEDURE - Operating Instructions for Inhaled Nitric
Oxide Therapy With Mechanical Ventilation
Policy 7.3.57
Page 4 of 7
Operating Instructions for Inhaled Nitric Oxide Therapy With
Mechanical Ventilation
Effective:
Reviewed:
07/03
5/31/05
Formulated: 07/03
Procedure
Continued
Initiation of Therapy with Conventional Mechanical Ventilation
Step
Action
2
Ensure that a purge has been completed within 5 minutes of
the start of therapy. If not, repeat the performance test as
outlined above and ensure that the NO2 level is less than the
values listed for the cylinder being used.
3
Position the injector module on the dry side of the humidifier
chamber, noting the airflow direction arrow on the module.
The injector module should not be placed directly off of the
ventilator in ensure accurate flow measurements.
4
Connect 6” extension tubing from the patient wye on the
inspiratory side of the breathing circuit to the sample tee,
distal to the temperature probe adapter. This extension
tubing minimizes sampling of mixed inspiratory/ expiratory
gases. See Appendix II.
5
Ensure that trigger sensitivity is set appropriately to prevent
auto-cycling, as the INOvent system subtracts gas from the
breathing circuit and can affect the sensitivity of flowtriggered breaths.
6
After connecting the INOvent delivery system to the patient
circuit, push the Set NO button and turn the control wheel
clockwise to increase the NO concentration or
counterclockwise to decrease the concentration. Push either
the Set NO button or the control wheel to confirm the set
concentration.
NOTE: NO delivery dilutes the therapy gas O2
concentration up to 10% depending upon the set NO
concentration.
7
After the monitored values have stabilized, set or change the
user-adjustable alarms to the appropriate ranges.
O2 alarms should be set + 5% of desired FiO2
NO2 high alarm should be set at 3.0 ppm
NO alarms should be set + 5 ppm of desired level
Continued next page
UTMB RESPIRATORY CARE SERVICES
PROCEDURE - Operating Instructions for Inhaled Nitric
Oxide Therapy With Mechanical Ventilation
Policy 7.3.57
Page 5 of 7
Operating Instructions for Inhaled Nitric Oxide Therapy With
Mechanical Ventilation
Effective:
Reviewed:
07/03
5/31/05
Formulated: 07/03
Procedure
Continued
Initiation of Therapy with Conventional Mechanical Ventilation
Step
Assessment
of Outcome



Action
8
Methemoglobin levels should be drawn one hour after the
initiation of therapy and checked q1 times four hours to
monitor for increases in methemoglobin.
9
A low range calibration of sensors needs to be completed
daily throughout the duration of therapy. Push the calibration
button to reach the first Calibration menu. Highlight the Low
Range (room air) NO, NO2, O2 option. Push the control
wheel to start the low range calibration. All three sensors
will calibrate automatically at the same time.
Arterial, venous and capillary blood gas values
Pulse oximetry
Pulmonary artery pressures
Infection
Control
Follow procedures as outlined Healthcare Epidemiology Policies and
Procedures: #2.24 Respiratory Care Services.
http://www.utmb.edu/policy/hcepidem/search/02-24.pdf
Safety
Precautions
Oxygen safety techniques as outlined in section 3.6 of the INOvent Manual
will be followed.
All alarms on ventilators will be activated at all times.
All alarms on INOvent delivery system will be activated at all times.
References
Sensormedics High Frequency Oscillatory Ventilator Operating Manual.
Whitaker, K., Comprehensive Perinatal and Pediatric Respiratory Care,
Delmar, Albany, New York, 2001.
Cornfield DN, Abman SH. Inhalational nitric oxide in pulmonary
parenchymal and vascular disease. Journal of Laboratory Clinical Medicine
1996 Jun; 127(6): 530-539.
Miller CL. Nitric oxide therapy for the persistent pulmonary hypertension of
the newborn. Neonatal Network 1995 Dec; 14(8): 9-15.
Angelucci P. A new weapon against ARDS…adult respiratory distress
syndrome. RN 1996 Nov; 59(11): 22-25.
Continued next page
UTMB RESPIRATORY CARE SERVICES
PROCEDURE - Operating Instructions for Inhaled Nitric
Oxide Therapy With Mechanical Ventilation
Policy 7.3.57
Page 6 of 7
Operating Instructions for Inhaled Nitric Oxide Therapy With
Mechanical Ventilation
Effective:
Reviewed:
07/03
5/31/05
Formulated: 07/03
Appendix I.
System Purge and performance test
WARNING: Make sure a purge has been completed within five minutes before the start of NO therapy. If
not, repeat the performance test as described here, making sure this is less than the value listed for the
cylinder concentration being used.
1. Connect the Injector Module to an O2 auxiliary flow meter using O2 tubing, a 4.5 mm to 15 mm
adapter and a breathing circuit adapter to condition the flow before the Injector Module. See figure
5-1.
2. Connect the sample line to the outlet of the injector module with 300 mm of 22 mm hose to ensure gas
mixing prior to gas sampling (see figure 5-1). Attach a sampling line from the sample tee to the
sample connector on the front panel.
1.
2.
3.
4.
5.
6.
7.
8.
9.
O2 Flow meter
O2 Tubing
15 mm x 4.5 mm Adapter
Injector Module
300 mm of 22 mm hose
Sample Tee
Inspiratory Gas Sample Line
NO/N2 Injector Tube
Injector Module Electrical Cable
Continued next page
UTMB RESPIRATORY CARE SERVICES
PROCEDURE - Operating Instructions for Inhaled Nitric
Oxide Therapy With Mechanical Ventilation
Policy 7.3.57
Page 7 of 7
Operating Instructions for Inhaled Nitric Oxide Therapy With
Mechanical Ventilation
Effective:
Reviewed:
Formulated: 07/03
Appendix II.
07/03
5/31/05