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Field trial of the Oxylator®
EM-100 in the Prehospital Setting
Taryn Kennedy MD*, Richard V Aghababian MD*, Robert
McGrath EMT-P.
*Dept. of Emergency Medicine, UMass Medical Center Worcester,
MA, 0165 USA;
UMass Emergency Ambulance Service Worcester, MA, USA
Abstract | Introduction
| Method | Results
| Discussion | Conclusion
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Abstract
Objective: To test the efficacy and ease of use of
an oxygen-powered resuscitator/inhalator to provide ventilatory
support in the prehospital setting. The bag valve device is
the current standard of care. This study uses the hypothesis
that the Oxylator is as effective as this current standard.
Method: We conducted a prospective randomized clinical
trial of the prehospital population requiring airway management.
We used a hospital-based paramedic service providing 911 emergency
care in an urban setting. All paramedics received 3 hours of
training prior to use of the device.
Results: Twenty-one patients were entered into the
study group and thirteen into the control group. Initial pulse
oximeter readings in the study group ranged from 59% to 99%
with a mean of 86%. The highest oximeter reading ranged from
84-100% with a mean of 98%. In the control group initial pulse
oximeter readings ranged from 64-95% with a mean of 84%.
The highest readings were from 84-100% with a mean of 96%. This
was not statistically significant. Using a numerical
scale of 1-5 to determine ease of use, cleaning and assembly
of the Oxylator, "very easy", was reported in
71.4%, 76.2%, and 80.9% respectively.
Conclusion: The Oxylator® EM-100 was found to be
a useful tool in the prehospital setting. No adverse outcomes
were described and pulse oximeter readings similar to those
obtained using conventional methods were recorded. Paramedics
and patients made favorable comments regarding its use. Further
studies will be needed but the Oxylator® EM-100 may prove
to be very useful in the prehospital.
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Introduction
The current standard of care for providing ventilatory support
in the pre-hospital setting is the bag valve. The purpose of
this study is to compare the efficacy of the Oxylator® EM-100
(CPR Medical Devices Inc Ontario, Canada) as an alternative
to this current standard. This device is used in place of the
bag- valve in conjunction with either a facial mask or an endotracheal
tube. The Oxylator is an oxygen-powered resuscitator/inhalator
and requires an oxygen source of 40 liters/minute at 50 psi
to function.
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Method
A prospective randomized trail was conducted in the prehospital
setting by hospital based paramedics providing 911 emergency
care in an urban environment. The population studied included
adults (>18 years age) requiring airway management whose
needs would normally be met by use of a bag-valve mask or bag-valve
endotracheal intubation.
The following exclusion criteria were used:
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Children less than 18 years |
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Asthmatics with active bronchospasm |
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Patients in full cardiac arrest
(apneic and pulseless) |
The study protocol was submitted to and met with IRB (Institutional
Review Board) approval prior to its initiation.
All paramedics involved in the study attended a mandatory three-hour
training session consisting of both a didactic lecture and hands
on teaching prior to use of the device. During this training,
the data collection sheet was reviewed and all participants
were familiarized with the consent form for patients enrolled
in the study.
The device, for purposes of the study, was only used during
patient transport, which was defined as the time the patient
spent in the ambulance itself. Randomization was based on the
day of the week, starting at 00.01 of the day in question. The
Oxylator (study group) was enrolled on Monday, Wednesday, Friday
and Sunday and control (bag valve) patients were entered on
the alternate days. Verbal consent was obtained from either
the patient or a relative by reading from a prepared handout
and a copy of this was then given to them.
All participants were encouraged to contact the study physicians
if they had any questions concerning the study and their involvement.
Patients were freely allowed to refuse to participate and in
such cases the bag- valve mask was used. Patient treatment was
not delayed or altered in any way while consent was obtained.
On arrival in the ambulance, an initial pulse oximeter reading
was obtained using Model 340-pulse oximeter (Palco Laboratories).
On study days the Oxylator was the used in conjunction with
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