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Clinical
and Technological Evaluation
of the Oxylator EM-100 Resuscitator
Miguel Rodriguez, MD
Intensive Care Department
Hospital Princeps d'Espanya Bellvitge
Barcelona, Spain
Objectives | Material and Methods | Discussion and Comments | Conclusions
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Objectives
| 1. |
Evaluate the performance, ease of
handling and operation of the EM-100 resuscitator through
clinical use by prescribing the various ventilation modes
in critical patients. |
| 2. |
Compare its effectiveness with ventilation
with bag-and-valve and pressure ventilators for resuscitation
and transportation. |
| 3. |
Evaluate its handling difficulties
for operators and user training options. |
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Material and Methods
| 1. |
EM-100 with complete
pack, including connections and output pressure regulator. |
| 2. |
Clinical study of the
various ventilation modes in critical patients, divided
into three groups: |
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Group
A. |
10 patients admitted
to the ICU receiving mechanical ventilation for respiratory
lung disease or extrapulmonary pathology. |
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Group
A1. |
Multiple injury patients in coma
with head injury, without respiratory disease (2 patients) |
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Group
A2. |
Multiple injury patients (chest
injury) with lung pathology (contusion + barotrauma) (3
patients) |
| |
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Group
A3. |
Acute exacerbation of chronic respiratory
failure due to pulmonary decompensation of infectious
etiology (2 patients) |
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Group A4. |
Respiratory failure of extrapulmonary
etiology - septic shock (2 patients) |
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Group A5. |
Acute obstructive respiratory failure
- severe asthma (1 patient) |
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Group
A6. |
Respiratory failure of mixed pulmonary
and extrapulmonary etiology (esophageal cancer with mediastinitis)
(1 patient) |
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AGE RANGE: Between 18 and 77
years
WEIGHT OF PATIENTS: Between 50-90 kilograms |
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Group
B. |
Transportation of a
number of the above patients from the emergency room to
the ICU or from the ICU to carry out CAT/arteriography
diagnostic tests |
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Group
C. |
Treatment outside of
the hospital of 10 critical patients with resuscitation
times (including onsite care and transportation to the
reference hospital) greater or equal to 20 minutes |
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Group
C1. |
Sudden death presumable cause ischemic
heart disease/heart valve disease 100% aspiration pneumonia
(5 patients) |
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Group C2. |
Multiple injury patients with head
injury (2 patients) |
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Group
C3. |
Severe respiratory failure
Cardiogenic shock
Pneumonia
Meningitis
(3 patients) |
In Groups A and B (hospital groups), the theoretical evaluation
was verified by continuous analysis of the saturation (SO2)
using a non-invasive percutaneous method for monitoring peropheral
oxygenation (finger pulse oximetry) and, in some cases, invasive
measurement with analysis of blood gases in order to ascertain
alveolar oxygenation and ventilation (measurement of PAO2, PCO2
and arterial pH). An analysis system also was used to measure
the concentrations of inhaled O2 and ongoing spirometry with
T-piece to measure the exhaled tidal volume.
In the patients belonging to Group C (extrahospital group),
only clinical parameters such as lung compliance/adaptation
to the various ventilation modes/peripheral oxygenation/skin/color/pulse
oximetry during transportation and/or capnography were observed.
In the patients in Group A, the cycling mode Automatic with
PEEP was used.
In the patients in Group B, the cycling modes manual and Automatic
with PEEP were used.
In the patients in Group C, both of the above mentioned modes
were used plus inhalation of enriched ambient air combined with
manual cycling.
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Discussion and Comments
In the patients in Group A1, mechanical ventilation maintained
for 10 minutes with the EM-100 gave mechanical ventilation and
oximetry values very close to ventilation with the Volumetric
Ventilator, without any significant differences in the PO2 and
blood pH.
In the patients in Group A2, the differences were significant
as regards the percutaneous SO2, obtaining SO2 less than and
equal to 8% on average but even so, acceptible as regards oxygenation
in critical stuations. O2 requirements in these patients were
< 100%.
The most significant variations were found in the patients in
group A3, with difficulties in maintaining ventilation with
the EM-100 due to two cases being in assisted ventilation and
CPAP weaning.
Ventilation with the EM-100 was stopped in the patient in Group
A5 after 5 minutes due to the appearance of bronchospasm with
clear increase in airway pressure requiring drug therapy.
In the patients in Group B, the results were extrapolatable
to those of the previous group with clear improvement in the
SO2 regarding oxygenation with 100% O2. In one of the cases,
ventilation had to be stopped due to a clear inability by the
patient to adapt to the resuscitator, without this being related
with hypoxia or bronchospasm. After sedation and drug-induced
muscle relaxation, readaption was correct with parameters similar
to the previous ones.
Where the resuscitator was shown to be most useful was when
it was used in the patients in Group C, particularly in subgroups
C1, C2 and C3, with very acceptible results in the clinical
screening, both during treatment on site and during subsequent
transfer to hospital.
In order to evaluate statistically significant results in use
outside of the hospital, it should be compared in a study with
pressure ventilators with spirometry, as it is clearly superior
when compared with ventilation with bag and valve. In the 5
cases with CPR (sudden death), after endotracheal intubation,
the EM-100 achieved ventilations with tidal volumes between
500-600 ml and respiratory rates between 12-18/minute with an
average setting of 45 cmH20. It is important to note the technologically
revolutionary change in approach designed into the operation
of the EM-100, with the implementation of the P-FAC concept,
compared with the self-programmable rate and volume ventilators
and the pressure setting between 25-50 cmH2O.
When training in its use, it is vital to monitor and control
clinical parameters such as chest excursion, skin color and
respiratory auscultation.
In Spain it is absolutely necessary that the system be equipped
with an operating pressure regulator set at 3,5 bar.
It would be interesting to adapt the connections both to the
EM-100 and to the oxygen source to the conventional outlets
used in Spain (quick-connect and wall outlets.)
In obstructive and restrictive lung disease, the standard ventilatory
features (I/E ratio) limit use but provide emergency ventilation
with a degree of guarantee similar to that of ventilators for
use during transportation except as regards indication by pressure
guage of the mean airway pressures (intratracheal pressures).
The EM-100 system could be equipped with a visual and/or audible
alarm system in the automatic mode.
We did not find any problems in the maintenance or disinfection
of the system.
No gastric distention was observed in any of the patients in
Group C (C2-C3).
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Conclusions
The EM-100 is a technological innovation of acceptible effectiveness
in emergency ventilation and oxygenation, requiring a different
mental outlook compared with programmable ventilators.
It is easy to operate and compactly designed, although it requires
training prior to field work.
It is shown to be suitable for the treatment of critical patients
outside of the hospital, both in CPR and during transportation
to hospital (for short periods), giving highly satisfactory
results.
It is acceptible with certain modifications in hospital transfers
(operating theatre-ICU-emergency room). Adaptation of spirometry
system and audible and/or visual alarms.
It is effective when used in a CMU IPPV system (controlled ventilation).
It has not been possible to evaluate its use in ventilation
modes like SIMV or CPAP.
Consequently, it would be suitable to use in EMS and, in certain
cases, for the evacuation or transfer of patients for short
periods within the hospital.
Its greatest strength is its ease of use, its compact design
and the possibility of guaranteeing mechanical ventilation matched
to the patient's respiratory parameters, even in critical situations.
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