Oxylator Overview by Jim DuCanto, MD

1. The Oxylator—A Compact and
Durable Patient Responsive
Ventilation System for
Resuscitation, Transport and
Ventilation Therapy.
James C. DuCanto, M.D.
Assistant Clinical Professor
Dept. of Anesthesiology
Medical College of Wisconsin
Director of Anesthesiology Clerkship
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin

2. 
The presenter has no conflict of interests or
financial interests regarding the technology
discussed in this lecture.

Dr. DuCanto has received demonstration
devices from CPR Medical Devices, Inc. for
investigations regarding ventilation in the
Operating room and during Transport.

3. What is an Oxylator?

A durable and portable ventilation tool that
appears similar in form to a “Demand Valve”,
but incorporates patient responsive technology
centered around a sensitive proprietary valve
technology that is 20 times faster than the
current generation of ventilators.

4. 
It is similar to a demand valve that has
transformed technologically into a system that
delivers Oxygen (or Air) based upon continual
monitoring of patient airway pressure, and relies
upon the free and unobstructed flow of gas into
the patient to permit its normal functioning.
-Oxylator works with:

Facemask (Anesthesia mask and BiPAP Mask)

Supraglottic Airways (Laryngeal Mask,
Combitube/Laryngeal tube)

Tracheal Tube

Ventilating Rigid Bronchoscope

5. The Oxylator Solves Several
Important Problems

Over-Ventilation during CPR and Resuscitation

Adequate Ventilation during continuous CPR
(without interruption at 100 compressions per
minute).

The Problem of Inconsistencies of Ventilation
with BVM's.

The Problem of the Patient Resisting the
Ventilation Equipment.

6. The Demand Valve
Pioneered EMS
Manual Triggered
Ventilation
Use curtailed in the
1980's due to the lack
of pressure limiting
safeguards.
Flow rates between
40 lpm to 160 lpm (!).

7. Goals in the Use of the Oxylator

Simplify and Improve Ventilation for Providers
of all Skill Levels.

Reduce the phenomena of hyperventilation during
CPR and resuscitation

Cerebral vasoconstriction

Documented reduction in survival with ACLS

Permit consistent ventilation regardless of rescuer
skill level.

8. 
In Essence, the goal is to Create an “AED” for
Ventilation.
-Device is gentle in its interaction with the patient,
limited in flow rates and pressures to eliminate the
potential complications of its ancestor, the demand
valve.

9. The “AED” of Ventilation (Europe)

10. How is the Oxylator More “Patient
Responsive” Than Our Current
Generation of Ventilation
Equipment?

The patient responsiveness is centered around
the unique proprietary valve technology which
operates according to a variable magnetic field
-Oxylator reacts 20 times faster to changes in flow
and airway pressure than the current generation of
ventilators
-Valve reactivity time is 17 millseconds (compared to
150-200 milliseconds for most other ventilators

11. Keys to the Oxylator's Patient
Responsiveness

Patience: Oxylator flow is limited to 30 lpm
(compared to 40-60 lpm with ventilators as well
as BVM's).

Perceptiveness: Oxylator flows until a peak
pressure is achieved, then activates a passive
exhaltory phase.
-This peak pressure is achieved when the patient
dictates it as so, i.e., when they feel the need to
exhale).

12. 
Our current generation of ventilation equipment
are NOT patient responsive—they force the
breath into the patient, often at the patient's
objection.
-Delivery of set rate and tidal volumes (or peak
pressures) lead to continuation of the inspiratory
phase of ventilation beyond the point of patient
tolerance

That's why patients “buck” the ventilator

Incoming breath limited by high pressure alarm setting

With BVM, patient responsiveness is limited to releasing
the bag when the patient coughs

13. History

An Innovation of a Paramedic in Ontario
Province, Canada (now deceased)
-Modify the demand valve to be patient responsive
using a similar magnetic mechanism to the Bird
Mark 7.
-Simplify resuscitation an transport of critically
ill/injured patients.
-Establish safeguards within the system to avoid
patient injury.

14. 
Technology acquired and refined by CPR
Medical Devices, Inc. in the late 1980's.
-Technology refined and made reliable and
reproducible on a mass scale.
-Over 30,000 Oxylators are in service today across
the world, the greater majority of them are in service
in Europe and Asia.

Munich Fire Department

National Health Service of Great Britain

National Health Service of Korea

US Military Special Forces (Airforce)

State of Georgia (Homeland Security)

15. BVM vs Oxylator

Variable Flow Rates (operator dependent).

Variable tidal volumes

Variable Minute Ventilation

Hyperventilation is common (Aufderheide,
et.al.).

17. Hyperventilation is Deleterious
During CPR
A clinical observational study
revealed that rescuers
consistently hyperventilated
patients during out-of-hospital
cardiopulmonary resuscitation
(CPR).
The objective of this study was
to quantify the degree of
excessive ventilation in humans
and determine if comparable
excessive ventilation rates
during CPR in animals
significantly decrease coronary
perfusion pressure and survival.
Circulation. 2004;109:1960-1965

18. 
In 13 consecutive adults
(average age, 63±5.8 years)
receiving CPR (7 men),
average ventilation rate was
30±3.2 per minute (range,
15 to 49).
-Average duration per breath
was 1.0±0.07 per second.
-No patient survived.

Hemodynamics were
studied in 9 pigs in cardiac
arrest ventilated in random
order with 12, 20, or 30
breaths per minute.
-Survival rates were then
studied in 3 groups of 7 pigs
in cardiac arrest.
-Survival rates were 6/7, 1/7,
and 1/7 with 12, 30, and 30+
CO2 breaths per minute,
respectively (P=0.006).

19. 
Recent findings:
-There is an inversely
proportional relationship
between

mean intrathoracic
pressure,

coronary perfusion
pressure,
-and survival from cardiac
arrest.

20. 
Increased ventilation rates and increased ventilation
duration impede venous blood return to the heart
-Decreasing hemodynamics and coronary perfusion
pressure during cardiopulmonary resuscitation.

There is a direct and immediate transfer of the increase in
intrathoracic pressure to the cranial cavity with each
positive pressure ventilation
-reducing cerebral perfusion pressure.

21. Oxylator Models

Multiple Models for various applications, all
work the same way.
-EM-100
-EMX
-FR-300
-HD
-“Special Hazardous Model” for Mining Industry

22. The Oxylator EM-100
The first commercially
available model circa
1994.
Pressure Release
(i.e., limit) range 25-
50 cm H2O.
In use by the Korean
National Health
Service since 2000?

23. 
Class I device
-Guidelines for CPR
and Emergency
Cardiac Care

Published studies are
limited to its use as a
resuscitator

24. Constructed for
effective use in
adverse environments
and circumstances
-Hazardous
Environments
-Mass Casualty
-Military

25. The Oxylator EMX
Intended for the EMS
Market
Pressure Release
(Limit) 20-45 cm H2O
EMX-B model
constructed for
explosive
environments.

26. The Oxylator HD
Intended for Hospital
use to fulfill a variety
of roles.
Pressure Release
(Limit) 15-30 cm H2O

27. Pressure Limits 15-50 cm H2O and
the Potential for Gastric Insufflation

The Absolute Pressure is a Static
measurement of gas performance in the airway.

Inspiratory Flow Rate is a Dynamic
Measurement, which better explains the
phenomena of Gastric Insufflation during mask
or SGA ventilation.
-A Dynamic Force is Required to open the Upper
Esophageal Sphincter (UES), which is a
“physiologic” structure, not an actual anatomic
apparatus.

28. High Gas Flows Open the UES

Dynamic Descriptions of Gas behavior describe
the conditions necessary to overwhelm the
UES
-Mass moved over a distance equal to force
-Tissue moved out from its relaxed position (upper
esophagus/UES) from pharynx to stomach requires
force to achieve this transfer of gas.

It is not the pressure—it is the speed at which
the gas is introduced to the system that
explains the Gastric Distension phenomena

29. How Can The Oxylator not
Contribute to Gastric Insufflation?

Maximum flow rate of 30 liters per minute does
not contain the energy to overwhelm the UES.

30. Basic Principles of Function

Inhalator Mode—Passive Insufflation of O2 at
15 lpm
-“T-Piece” Mode
-Patient will entrain room air during spontaneous
ventilation
-Activated with turning the Inhalator knob to open
-Can be used concurrently with the Manual and
Automatic Modes (Active insufflation of Oxygen to
the release pressure).

31. 
Inhalation Phase Active (Insufflates 30 lpm O2).
-Manual Mode (Press and release Oxygen Release
Button

Inspiratory Time according to Rescuer or until Pressure
Release Setting Reached, then Passive Exhalation Phase
Activated
-Automatic Mode (Press and lock Oxygen Release
Button Clockwise Rotation)

Oxylator will Insufflate O2 to the Release Pressure

Following Passive Exhalation Phase (Airway Pressure 2-4
cm H2O), a New Inspiratory Phase will Begin.

32. 
Exhalation Phase passive to airway pressure of
zero (Manual Mode) or 2-4 cm H2O (Automatic
Mode).

Minute Ventilation 12-13 lpm.
-Slightly hyperventilates patient (EtCO2 29-31 during
clinical anesthesia).

Rescuer/Clinician selects mode of operation
with a single button.

33. Inhalation Phase

Triggered by the Oxygen Release Button
-Depressed intermittently (Manual Mode) or
constantly (Automatic Mode).

Inhalation rate limited to 30 liters per minute
(lpm).

Minimal PEEP 4 cm H2O in automatic mode.

Inhalation phase ends with either the cessation
of flow, or the attainment of the Pressure limit
(set by the Pressure Release Selector).

34. 
Exhalation Phase
-Passive
-Minimal PEEP 4 cm H2O in automatic mode.

A new respiratory cycle (in automatic mode) will
not begin until the exhalation cycle is complete
-Airway pressure between 2-4 cm H2O

35. How Does The Oxylator Work?

Flow Triggered Oxygen Delivery to an
Adjustable Pressure Limit (Release)
-Flow begins with activation of device and continues
until a set pressure limit is reached, then initiates a
passive exhalation phase which continues until the
airway pressure falls to between 2-4 cm H2O
(Automatic mode).
-The Oxylator will not start a new respiratory cylce
until exhalation is complete

36. Activation of the Oxygen Release
Button

Gold Button (all
Oxylator Models)

Begin Inhalation flow
rate 30 liters per
minute (lpm)
-Flow is low enough to
prevent esophageal
sphincter compromise
during mask and SGA
ventilation

37. 
Inhalation flow rate 30 liters per minute (lpm)
-Flow is low enough to prevent esophageal sphincter
compromise during mask and SGA ventilation

38. 
Connections for Face mask, supraglottic airway
or Tracheal Tube---15 mm and 22 mm
connections.
-Also adaptable to ventilating rigid bronchoscope

Airway obstruction interpreted by the Oxylator
as a No-Flow state—device will cease oxygen
flow and will NOT overpressurize the patient's
airway.

39. Anatomy

43. Operating Requirements

Operating Pressure of 55 psi (optimal)
-Device will function between a range of supply
pressures from 40 psi to 90 psi due to an integral
second stage regulator.

Medical Oxygen or Air from main hospital
supply

Medical Oxygen from tank (DISS Outlet)

Medical Air from Compressor
-Mass Casualty/Military

44. Training Requirements

Familiarization with proper compressed gas
handling procedures (Tanks and Regulators)

Familiarization with Three Modes of Operation:
-Inhalator Mode (Spontaneous Ventilation)
-Manual Mode (Oxygen Release button depressed
intermittently)
-Automatic Mode (Oxygen Release button locked in
depressed position)

45. 
Mask ventilation technique
-Mask fit and seal
-Jaw thrust, Head Tilt
-Oral Airway if needed

46. Advantages of Oxylator During
Mask Ventilation

Two-Handed Mask Ventilation Technique
without a Second Rescuer (Oxylator in
Automatic Mode).

Instant Feedback as to the Adequacy of Airway
Management Maneuvers
-Mask Leak—Oxylator Continues to Flow Without
Pressure Cycling
-Obstructed Airway—Oxylator will “Chatter” or will
not Flow oxygen at all

47. 
Patient Responsiveness
-When examined in the Draeger facility in Europe,
the valve reactivity time was measured at 17
milliseconds.
-Oxylator has the ability to react to changes in airway
flow and pressure as fast as 17 milliseconds

This is a rate that is 20 times faster than the human
nervous system can react

The patient thus sees the Oxylator as something that
reacts instantly to changes in patient airway patency and
compliance.

48. Cleaning and Care

49. Clinical Utility and Versatility

Labor saving device

Leaves Rescuer free
to attend to other
tasks

Uniform Delivery of
Ventilation

Immediate
Notification of Airway
Obstruction through
device

50. Future Potential