Investigation of the safety of ventilation with Ventrain in patients during a planned operation

Ventrain® is the first ventilation device that provides adequate ventilation
through a narrow-bore catheter, even in case of a completely obstructed upper
airway. Ventrain®, a product specifically designed for *cannot intubate, cannot
ventilate* emergencies, makes airway management in such life-threatening
situations easier and safer. With Ventrain, we have full ventilation through
only a 2 mm catheter.
Ventrain® not only insufflates oxygen, but also provides active removal of
gas from the lungs: expiratory ventilation assistance, or in short EVA.
EVA shortens the expiration time, increases the achievable minute volume and
prevents air trapping. Therefore, Ventrain® considerably reduces the chance
of intrapulmonary pressure build-up and the associated risks of barotrauma
and circulatory collapse. Active expiration is created by the special design
that optimizes a
balance between the Venturi effect and jet entrainment.
Ventrain® has been used in several cases of emergency of which several cases
have been published (ref). It has even been used in two life-saving airway
emergencies in neonates (ref).
These publications have been single cases. Despite several tests in animals and
lung simulators, there are still some worries for high pressures during
ventilation. In the present study we would like to demonstrate the safety of
ventilation (during 5 minutes) with Ventrain® in a series of patients prepared
for an operation. During reanimations generally no pressure or other
measurements are performed. During these controlled and well planned
ventilations these measurements can be performed.

Demonstrate the safety and efficacy of ventilation with Ventrain® during 5
minutes. Safety is demonstrated if the peak pressure during insufflation does
not exceed 25 cm H2O and PEEP (Positive End Expiratory Pressure) is not smaller
than -5 cm H2O and not higher than 6 cm H2O.

1. Patients are approached to participate in the study during the pre-operative
period by the anaesthesist.
2. Patients will have at least 1 week to think about the study and will then be
approached for their answer.
3. Patients willing to be included will be planned for an OR at a time that the
study can be performed.
4. For the OR an additional +- 15 minutes will be scheduled.
5. All patients will be intubated as usual with a tube of 7-8 mm. The tube is
prepared on the OR with an airway exchange catheter Cook 3 mm and with a line
for pressure measurements. The insertion of these materials will be facilitated
by wetting the materials with sterile water.
6. The prepared tube will be brought into the patient.
7. From the moment that the ventilation of the patient starts two persons will
be available for the ventilation. The first person (named dr B, as he will be
blind for the pressure measurements) will perform the ventilation with the
Ventrain. Dr B will only look at the patient and its chest.
8. The second person (dr C will control the pressures and makes sure that the
patient never gets the boundaries of the pressures as stated earlier in the
protocol. Dr C has the right and is obliged to finish the experiment at the
moment the pressure boundaries are reached.
9. Dr B will use the Ventrain® as stated in the instructions for use, which
means that after 5 ventilation cycles the Ventrain® is opened until the chest
is in rest.
10 As a small tidal volume is preferred, the ratio of inspiration and
expiration will be 1:1, which means 1 second inspiration and 1 second
expiration.
11. The flow of the 100% oxygen will be set at 15 L/min.
12. The ventilation will be performed with the Ventrain® during 5 minutes.
13. After 5 minutes the Cook catheter and line for pressure measurements will
be withdrawn from the tube. The 7-8 mm tube stays in situ during the following
OR period.
14. The ventilation of the patient will be continued as normal.
15. Several measurement will be continued during the first 5 minutes of
ventilation, such as oxygen saturation, heart rhythm and tension.
16. The OR will continue as usual. The experiment has ended.

The risk can be compared with the risk around normal operation procedures and
each ventilation procedure.
The safety is guaranteed as a second person is taking care for the monitors and
he/she will intervene if necessary.
The burden for the patient will be limited to a prolonged narcosis of maximal
15 minutes. We assume it will be around 5 minutes.