Clinical Evidence

The Effects of Oxygen Therapy on Myocardial Salvage in ST Elevation Myocardial Infarction Treated with Acute Percutaneous Coronary Intervention

LUND UNIVERSITY

Objective:

Oxygen therapy is a common treatment for patients who are experiencing heart failure, although there is a lack of evidence supporting its benefits.

Methods:

In the ambulance, 100 “normoxic STEMI” patients are randomly divided into one of two groups. Either they receive supplemental oxygen or they do not. These patients are followed throughout their hospital stay and for 6 months after. OxyMask was chosen as the oxygen delivery device for this study because of the open designs’ “no CO2 retention”. Thus allowing them to place a mask each patient, but not having to turn on oxygen to flush out expired CO2.

Discussion:

Is supplemental oxygen harmful to heart failure patients.


OxyMask™ Whitepaper
Advancing Oxygen Therapy for Better Patient Care

Abstract:

OxyMask™ is one of the latest breakthroughs in advanced oxygen delivery technology. It features an open design that is ideal for patients whose oxygen requirements vary throughout their hospital stay. Clinicians can respond to a patient’s changing oxygen needs simply by increasing or decreasing oxygen meter flow from 1 litre per minute (lpm) up to flush (>15 lpm) to deliver 24%-90% FiO2 and maintain the desired SpO2. OxyMask™ is designed to deliver a broad range of oxygen in a safe and effective manner.
OxyMask™ delivers supplemental oxygen via a ‘virtual reservoir’ formed by a vortex of oxygen flow directed at the patient’s mouth and nose through a patented pin and diffuser assembly.
The large openings in the OxyMask™ design provide multiple patient benefits allowing the wearer to communicate effectively with caregivers and drink fluids. Higher humidity room air is drawn in through the mask openings as the patient inhales. This usually negates the need to use additional devices to humidify the delivered oxygen.
Mask openings also allow the patient to feel less claustrophobic, significantly improving patient comfort and compliance with their oxygen therapy.
Most importantly, the open mask design improves patient safety allowing carbon dioxide (CO2) to escape the mask on exhalation, reducing the risk of CO2 rebreathing and potential sentinel events.


Southmedic OxyMask compared to the Hudson RCI Non- Rebreather Mask. – A Look at Safety and Performance.v

Keith Lamb. December 2015

Background:

The non-rebreather mask (NRBM) is used for many applications and in many patient care scenarios in which hypoxemia and resultant hypoxia are a concern. The NRBM is a low-flow oxygen delivery system that is easily deployed and capable of delivering a relatively high fraction of inspired oxygen (FiO2).The potential for ineffective carbon dioxide (CO2) removal at low flow rates is a safety concern.

Objective:

The authors hypothesized that the use of an OxyMask™ (Southmedic Inc, Canada) would mitigate these safety concerns while still delivering a relatively high FiO2.

Methods:

Bench studies were performed in a third-party laboratory by qualified engineers (Piper Medical, USA). A Harvard Respirator Pump (Harvard Apparatus, USA), oxygen source, CO2 source and a mannequin head were used to simulate varying respiratory conditions. End tidal CO2 (EtCO2), FiO2, fraction of inspired CO2 and percent drop in CO2 in the first second of exhalation were measured at different mask flow rates and respiratory rates. There were two categories of flow rates: high-flow (15 L/min) and low-flow (2 L/min). In each flow group, the above parameters were measured using a tidal volume of 400 mL, inspiratory/expiratory ratio of 1:2, EtCO2 of 5% and a breathing frequency of 15, 20 or 24 breaths/min. Mask performance measurements were obtained and compared.

Conclusion:

The OxyMask™ outperformed the traditional NRBM in each tested category. There was a higher inspired oxygen level, lower inspired CO2 level, and more efficient CO2 clearance at each mask flow level and simulated patient minute volume. This was especially true during conditions in which there were very low mask flow rates.


An Evaluation of the Prototype OxyMulti Mask Prototype Compared to the Oxymask™ Aerosol, OxyMulti Mask™ and Airlife™ Aerosol Mask for Aerosol Delivery in Adults.

Rush University, College of Health Sciences, Respiratory Care Program, Aerosol Lab. Meagan N. Dubosky MS, RRT-ACCS, NPS, AE-C. 2/7/2014.

Objective:

To compare the amount of drug delivered to an in-vitro, spontaneously breathing, adult lung model using four different aerosol masks; Prototype OxyMulti Mask, Oxymask™ Aerosol, OxyMulti Mask™ and Airlife™ Aerosol mask. To evaluate the effect these four masks (Prototype OxyMulti Mask, Oxymask™ Aerosol, OxyMulti Mask™ and Airlife™ aerosol mask) have on particle size using common delivery devices.


Infantile Hypophosphatasia Associated with Respiratory Insufficiency.

Heliox Abstract AARC 2011.

Introduction:

We report the successful use of chronic mechanical ventilation (MV) in an infant diagnosed with infantile hypophosphatasia (IHPP) who developed chronic respiratory failure.


The OxyMask™ development and performance in healthy volunteers.

James E Paul, Horia Hangan, Julius Hajgato. Department of Anesthesia – HSC – 2U1. McMaster University. 2009.

Background:

The OxyMask™ is a unique, open-style, oxygen mask that was originally developed in 2005. The original mask was modified, using computational fluid dynamics numerical simulations, with the goal of allowing it to produce a wider range of FiO2. This analysis was used to guide the modification of the mask shell and the location for the oxygen diffuser.

Methods:

The new OxyMask was attached to 10 healthy subjects and used to deliver escalating levels of oxygen (1.5, 2, 2.5, 3, 5, 10, 15, 20, 25 and 30 LPM) for 90 seconds at each level and the resulting FiO2 was recorded (at the lips) from 5 consecutive measurements at each oxygen flow rate.

Results:

Mean FiO2 was 25.4% at 1.5 LPM of oxygen, 30.1% at 2 LPM, 36.5% at 2.5 LPM, 41.8% at 3 LPM, 57.6% at 5 LPM, 74.4% at 10 LPM, and 80.1% at 15 LPM. Each FiO2 achieved at these escalating oxygen levels was significantly greater than all the previous levels. The mean FiO2 was 82.8 at 20 LPM, 84.2% at 25 LPM and 84.3% at 30 LPM. All of these values on average were not significantly greater than the FiO2 achieved with 15 LPM. In a few subjects a maximum FiO2 of 90% was reached.

Conclusion:

The original OxyMask was successfully modified so that the second generation of the mask can provide a wide range of FiO2, from 25% to 90%, while keeping its unique open design.


The OxyMask™ development and performance in healthy volunteers

James Paul BSc MD MSc FRCPC , H. Hangan, Julius Hajgato CET Medical Devices: Evidence and Research 2009:2

Background:

The OxyMask™ is a unique, open-style, oxygen mask that was originally developed in 2005. The original mask was modified, using computational fluid dynamics numerical simulations, with the goal of allowing it to produce a wider range of FiO2. This analysis was used to guide the modification of the mask shell and the location for the oxygen diffuser.

Methods:

The new OxyMask™ was attached to 10 healthy subjects and used to deliver escalating levels of oxygen (1.5, 2, 2.5, 3, 5, 10, 15, 20, 25 and 30 LPM) for 90 seconds at each level and the resulting FiO2 was recorded (at the lips) from 5 consecutive measurements at each oxygen flow rate.

Results:

Mean FiO2 was 25.4% at 1.5 LPM of oxygen, 30.1% at 2 LPM, 36.5% at 2.5 LPM, 41.8% at 3 LPM, 57.6% at 5 LPM, 74.4% at 10 LPM, and 80.1% at 15 LPM. Each FiO2 achieved at these escalating oxygen levels was significantly greater than all the previous levels. The mean FiO2 was 82.8 at 20 LPM, 84.2% at 25 LPM and 84.3% at 30 LPM. All of these values on average were not significantly greater than the FiO2 achieved with 15 LPM. In a few subjects a maximum FiO2 of 90% was reached.

Conclusion:

The original OxyMask™ was successfully modified so that the second generation of the mask can provide a wide range of FiO2, from 25% to 90%, while keeping its unique open design.


OxyMask vs Non-Rebreather Mask – A Pressure Comparison Julius Hajgato

June 2008

SUMMARY:

A surface pressure test was conducted between the OxyMask, a generic Non-rebreather O2 mask and a Partial Non-rebreather O2 mask. Surface pressure was measured inside all three devices, on flow rates of 15, 30 & 60 LPM. It was determined that positive pressure could be significantly increased within a closed mask system, like the Non-Rebreather, when flow rates exceed manufacturer’s specifications. The positive pressure realized during this test along with the clinical findings notes in “Tobin A, Groves N, High Flow nasal oxygen generates positive airway pressure in adult volunteers. Australian Critical Care (2007) 20, 126-131” gives technical evidence and clinical credence to the fact that intrinsic PEEP can indeed be administered during high flow oxygen therapy.


Oxygen and Helium Delivery Concentrations for the Southmedic OxyMask and a Non-Rebreather Mask with 80-20 Heliox as Measured at the Mouth.

Date: January 25, 2008 – Protocol 08-0002. Dave Piper, PE; Piper Medical Products

PROTOCOL:

Oxygen and Helium Delivery Concentrations for the Southmedic Oxymask and a Non-Rebreather Mask with 80-20 Heliox as Measured at the Mouth.

OBJECTIVE:

To measure to the oxygen and helium delivery of the Southmedic Oxymask and a standard non-rebreather mask when used to deliver 80-20 heliox under simulated patient conditions of a respiratory rate of 15 bpm, a minute ventilation of 10 l/min, and, and a I:E ratio of 1:1.


Oxygen Delivery Performance of the Southmedic Infant Mask under Simulated Patient Conditions.

Date: January 16, 2008 – Protocol 07-0086

OBJECTIVES:

To measure to the oxygen delivery of the Southmedic Infant oxygen mask when deliverying 250, 500, 750, 1000, 1500, 2000, 2500, 3000 ml per minutes of oxygen for a simulated patient condition of 50ml tidal volume, 30 bpm breathing rate, and an I.E. ration of 1:1.


The OxyArm™: A Supplemental Oxygen Delivery Device

James W. Futrell Jr., MD, and Jack L. Moore, MD. Department of Anesthesiology, Cedars-Sinai Medical Center, Los Angeles, California; Department of Anesthesiology, Kaiser Permanente Medical Center, Bellflower, California. Anesth Analg 2006; 102:491-4

Facemasks and nasal cannulae are used to provide supplemental oxygen to patients in the postoperative period after general anesthesia. These devices are associated with several patient complications, including aspiration, hypercarbia, and mechanical trauma. A new device, the OxyArm™, is designed to eliminate these problems. It is an “open oxygen” system that does not require physical contact with the patient’s face. In this clinical study we evaluated the OxyArm™ in the immediate postoperative period. Sixty patients received supplemental oxygen via the OxyArm™ for the first 8 min after tracheal extubation after general anesthesia. Oxygen saturation values were continuously recorded during 3 4-min time periods: 1) while breathing oxygen through an endotracheal tube before tracheal extubation, 2) while breathing oxygen delivered by the OxyArm™ at 4 L/min 4 min after tracheal extubation, and 3) while breathing oxygen delivered by the OxyArm™ at 2 L/min 8 min after tracheal extubation. There were no significant differences in oxygen saturation among the three time periods and no patient experienced an oxygen desaturation event less than 88%. Patients and clinicians praised the OxyArm™ for its comfort and ease of use, allowing nursing facial care without interrupting oxygen therapy. We conclude that the OxyArm™ delivers adequate levels of oxygen for most patients during the early postoperative period.


Aerosol Performance and Comparison of the Southmedic OxyKid Nebulizer Mask to Four other Aerosol Masks while delivering Albuterol during Simulated Breathing.

Date: October 24, 2006 – Protocol 06-0033 David Piper, PE; Piper Medical Products

OBJECTIVES:

To compare the total dose, mass median aerodynamic diameter (MMAD), geometric standard deviation (GSD), respirable mass fraction (0.5-5), respirable mass, and treatment time of the Southmedic OxyKid Aerosol Mask to a hybrid OxyKid, Mask 45, and Aerosol mask when operating under conditions of adult simulated breathing and while aerosolizing sulfates (2.5 mg / 3ml) with a Nebulizer.


Numerical Simulation of the Flow and Concentration Fields of Oxygen Delivery Systems

H. Hangan, S. Bekele, Journal of Biomechanical Engineering, Vol 125, October 2003

The flow and concentration fields for various medical oxygen delivery devices are numerically investigated. Simulations are performed for a classical Venturi mask and two new OxyArm™ portable devices. The velocity and oxygen concentration fields are investigated for: (i) a constant (steady-state) inhalation and (ii) a complete respiratory cycle (unsteady). The numerical results are qualitatively compared with clinical trials. It is found that the optimal functioning of these medical devices implies a lance between oxygen delivery by advection and the mixing process that allows for reliable CO2 monitoring (capnographic capability). Also, at the typical scales associated with these devices the flow is found to be Reynolds number dependent.


A Comparison of the OxyArm™ Oxygen Delivery Device and Standard Nasal Cannulae in Chronic Obstructive Pulmonary Disease Patients.

Timothy Dinesen, PhD MBA, Lee McDonald, RN, Sandy McDonald, MD and Donald DuVall, MD. Author Affiliations Dinesen Research Group, Toronto, Ontario, Canada Southmedic, Barrie, Ontario, Canada.

OBJECTIVE:

Compare the performance of the OxyArm to that of nasal cannulae in the delivery of supplemental oxygen to patients with chronic obstructive pulmonary disease.

METHODS:

We tested various oxygen flows with 10 chronic obstructive pulmonary disease patients who were receiving prescribed supplemental oxygen. Blood oxygen saturation (measured via pulse oximetry [SpO2]), was measured with each device, and mean data were compared with paired, 2-sample t tests. RESULTS: Mean SpO2 was equivalent with OxyArm™ and nasal cannuae for 7 of the 10 subjects, over a range of oxygen flows (2-5 L/min). Mean SpO2 was higher with the OxyArm™ with 2 subjects and lower with 1 subject (p < 0.01).

CONCLUSION:

The OxyArm™ maintained stable SpO2 over the range of oxygen flows studied and at levels equivalent to those maintained by nasal cannulae in 9 of the 10 subjects. The OxyArm™ does not contact the face and may be ideal for patients on long-term home oxygen therapy.


Leveraging Technology to Maximize Efficiencies in Today’s Challenging Respiratory Care Environment.

Cheryl Hoerr, MBA, RRT, CPFT, FAARC, Director, Respiratory Services, Phelps County Regional Medical Center, Rolla, Missouri.

The challenges imposed by healthcare reform are having an effect on the respiratory care landscape similar to the effect the tsunami had on the landscape of Japan; long established standards of care and traditional care delivery services cannot survive in such a financially challenging environment and are rapidly being assessed and modified to accommodate our new understanding of quality and effectiveness. To ignore the massive changes facing us and maintain the status quo is to deny the unsustainability of healthcare expenditures and put our ability to provide excellent patient care at risk. Spending on healthcare is estimated at 17.3% of our Gross Domestic Product (GDP) and translates into over $2.3 trillion in costs per year1, an expense that is clearly unsustainable.