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

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.

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.

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

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.

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 (!).

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.

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.

The “AED” of Ventilation (Europe)‏

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

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).

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

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.

Technology acquired and refined by CPR Medical Devices, Inc 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)‏

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

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

In 13 consecutive adults (average age, 63±5 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).

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

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.

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

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?

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

Constructed for effective use in adverse environments and circumstances Hazardous Environments Mass Casualty Military

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

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

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.

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

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.

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).

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.

Minute Ventilation 12-13 lpm. 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.

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).

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

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

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

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

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.

Anatomy

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

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)‏

Mask ventilation technique Mask fit and seal Jaw thrust, Head Tilt Oral Airway if needed

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

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.

Cleaning and Care

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

Future Potential