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EFFECTIVENESS OF THE USE OF THE
OXYLATOR® EM-100
Minassian A. M., Aghababian R., Ciottone G., Manukian
G. P., and Boshyan A. R.
Emergency Department, Emergency Scientific Medical Center, Yerevan
Introduction | Study
Group and Methods | Results | Discussion
| Conclusions | Acknowledgments
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Introduction
Ventilating patients during emergency procedures is usually
performed under stress and demands a very high level of proficiency,
attention and dexterity. In the pre-hospital setting, and in
the emergency room, the devices under current use ae BVD's (Bag
Valve Devices), ATV's (Automatic Transport Ventilators), and
in some cases highly sophisticated ventilators. The most commonly
used device is the BVD due to its cost and portability, however
studies and experience have shown that BVD's do not provide
adequate ventilation, cause gastric insufflation, and are not
patient friendly devices during assisted ventilation. Furthermore,
BVD's require continuous training and retraining in an attempt
ot maintain the level of proficiency required to try to perform
adequate mechanical ventilation in stressful situations. recently
introduced, the Oxylator® EM-100 resuscitator-inhalator
device addresses the issues which have compromised the ability
of emergency personnel to ventilate adequately and efficiently.
The effectiveness of the Oxylator® EM-100 was studied to
determine its effectiveness in the emergency setting both in,
and out of hospital. the evaluation performed also assessed
its practicality, flexibility, user friendliness, and durability.
The device is portable, small, and provides three modes of ventilation
functions. It is a gas powered (O2) device which
delivers a constant flow of 36 L/min during inspiration, and
shuts off all flow during expiration, thus conserving available
oxygen supply when used out of hospital. The inspiration phase
of the breath cycle is pressure limited between 25 and 50 cmH2O.
The exhalation phase of the breath cycle is always passive.
Manually triggered breaths are activated by simple depression
of a button, and continue until the button is released, or the
maximum selected pressure limit is reached and the system terminates
flow to the patient, and subsequently passive exhalation begins.
Automatic mandatory and assisted breaths are provided upon depression
of the same button, followed by its rotation to a locking position.
This mode continues to provide a pressure limited inspiration
phase, followed by a flow monitored expiration phase, hence
the next inspiration phase is flow triggered (expiratory) when
PEEP level of 2 to 4 H2O is reached. A 15 L/min free
flow may also be selected for conscious, breathing patients
in need of a higher concentration of O2.
The device incorporates some very unique features which assist
in better airway management, these will not be mentioned in
this study in detail, however it is noteworthy to mention.
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Study Group and Methods
The study group (controlled and investigated) consisted of 41
cases, all over 10 kg body weight, requiring assisted ventilation
fro different pathological profiles in the emergency and intensive
care departments as well as intra-hospital transport. The patients
were monitored for SO2 levels during ventilation with the device.
Due to the lack of other sophisticated equipment (capnograph
etc.), and the conditions under which the study was carried
out, we were limited to gather further information for analysis.
The conditions under which the the Emergency Center operates
are less than desirable, for instance, the momentary loss of
power to the hospital necessitates alternate ventilation support
in the Emergency unit for those patients supported by an ICU
ventilator (PB).
The persons using the Oxylator® EM-100 were trained by the
manufacturer, the training time was less than 2 hours, and was
conducted as a group. The group consisted of emergency physicians,
anesthesiologists, nurses, and EMTs working in conjunction with
the ambulance service.
The equipment used were the Oxylator® EM-100s, portable
oxygen tanks (600 L capacity) with 3.5 bar regulated output
pressure, masks and endotracheal tubes, pulse oximeters. 2 ambulance
technicians and 4 emergency physicians were allowed to initiate
the ventilation support with the Oxylator® EM-100, nurses
and/or EMTs were requested to observe and adjust the device
if required.
The evaluation was performed based on the existing reports and
studies previously performed in reputable institutions around
the world 1, which have demonstrated acceptable clinical performance
values and outcome. The evaluation of the Oxylator® EM-100
was to establish the applicable scope of the device within the
emergency environment, determine its acceptability as an alternative
device to BVDs, and its extended capability as a short-term
transport ventilator.
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Results
The 41 cases occurred within a period of 14 months under the
supervision of the Chief of Intensive Care at the Emergency
Center. The device was used in different modes, depending on
the requirements of the patient, the following table shows the
usage.
| Mode of use |
Frequency |
Total time (min.) |
% total use |
|
| nhalation |
25 |
630 |
52.5 |
| Manual trigger |
2 |
10 |
0.1 |
| Manual with PEEP |
0 |
0 |
0.0 |
| Automatic cycle |
22 |
560 |
47.4 |
Of the 41 cases 12 cases were subsequently transferred to the
ICU ventilator (PB), 21 cases did not require further ventilatory
assistance, 4 cases required periodic inhalation assistance,
2 cases where the device replaced the ICU ventilator during
electrical power interruption. In one case the device successfully
ventilated a patient requiring transport/CT Scan /return transport
procedure which took 124 minutes to complete.
The observations indicated satisfactory, and/or improved conditions
in 37 cases, no improvement in 3 cases, discontinued ventilation
in 1 case. The oxygen saturation levels of those cases with
satisfactory, and/or improved conditions all reached readings
of 94-96%. No cases of gastric insufflation, and stacking of
breaths were observed in any of the patients.
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Discussion
The use of the Oxylator® EM-100 within our Emergency Department
indicated the following:
| 1. |
It is appropriate and safe for use
by all persons who have minimal training in mechanical
ventilation. |
| 2. |
It is a very simple device which
permits the user to monitor the patient's airway patency,
and react, and make optimal adjustments. |
| 3. |
The device is perfectly suited for
excellent mask seal and jaw thrust manoeuvres as both
hands are available at the patient's head, this provides
a tremendous advantage over Bag Valve Devices. |
| 4. |
The small size of the device permits
the user to ventilate in restricted conditions where Bag
Valve Mask ventilation would have been impossible. |
| 5. |
Oxygen use of the device was limited
to the minute volume delivered to the patients, average
use time of the pressurized tanks (600 L, 'Jumbo' D size
) was in excess of 40 minutes. |
| 6. |
The ability of engaging the device
in automatic cycling mode enables the user to concentrate
on other necessary elements of emergency care, while continuously
monitoring the cycling rhythm by the devices regular 'clicking'. |
| 7. |
The Oxylator® EM-100's ability
to assist a breathing patient eliminated 'fighting the
ventilation cycle' during mandatory ventilation, it is
a transparent transition since the device is merely reacting
to the changes in the patient's airway. |
| 8. |
Maintenance was easily carried out
with cold disinfection and filter replacement. |
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Conclusions
We have come to several important conclusions as a result of
our evaluation with the Oxylator® EM-100.
| 1. |
The device is very practical to
use in the emergency environment, its different modes
of operation allow the user optimum flexibility of use. |
| 2. |
Oxygen saturation levels indicated
a marked improvement with the use of the device in 90%
of the cases treated. |
| 3. |
The device's ability to indicate
airway patency makes it the only device used in emergency
ventilation to indicate to the user of effective ventilation. |
| 4. |
There was no indication of barotrauma,
gastric insufflation, and, stacked breath in any of the
cases treated. |
| 5. |
The system is very easy to maintain
and durable, it will withstand use and abuse in the field
and the hospital environment. |
| 6. |
It is an ideal resuscitator, inhalator,
and short-term transport ventilator all combined in one
very small, hand held device. |
| 7. |
Instruction the potential users
should not take more than 2 hours maximum for them to
use the device to its full potential, and retraining the
users is not necessary. |
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Acknowledgments
We would like to thank UMass Department of Emergency Medicine,
U.S.A.; CPR Medical Devices Inc., Canada for making this evaluation
possible, by supplying the test equipment, and the time to train
our evaluation team at the Emergency Scientific Medical Center
in Yerevan.
Minasian, A. M.
M.D.Ph., Professor
Director, Emergency Scientific Medical Center
Chairman, Emergency Medicine
Yerevan, Armenia
Aghababian, R.
Professor of Medicine
Chairman Department of Emergency Medicine
University of Massachussetts, Worcester, Massachussetts, U.S.A.
Ciottone, G.
Director, Institute for Disaster and Emergency Scientific Medical
Center
Instructor of Emergency Medicine
University of Massachussetts Medical Center, Worcester, MA, U.S.A.
Manoukian, G.
Chief of Emergency Department
Emergency Scientific Medical Center
Yerevan, Armenia
Boshyan, A.
Assistant Professor of Emergency School
National Institute of Health
Yerevan, Armenia
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