Patients With Acute Hypercapnic Respiratory Failure Clinical Trial
Official title:
A Pilot Study on the Use of Extracorporeal CO2 Removal During the Weaning Process From Mechanical Ventilation
Weaning from invasive mechanical ventilation is one of the major clinical problem especially
ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania.
The aim of this pilot feasibility and safety trial is to assess the possibility of shorten
the duration of mechanical ventilation using a device able to remove CO2 and theoretically
able to allow therefore the praecox extubation
Weaning from invasive mechanical ventilation is one of the major clinical problem especially
ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania.
Up to 60% of the ventilatory time is devoted in these patients to the process of weaning.
These patients very often fail several weaning attempt, when a T-piece trial method is used.
In this case they are also very likely to require tracheotomy.
In this study we will enroll those still hypercapnic patients fitting the criteria of
readiness to be wean (i.e. clinical stability, normal sensorium and good cough reflex) and
failing a T-piece trail because of a rise in PaCO2 (>20% from baseline) and/or a rapid
shallow breathing index (f/VT)> 100.
After the unsuccessful trial they will be reconnected to the ventilator and they will repeat
hours later the same T-piece trial once the extracorporeal CO2 removal device (DeCap) will
be connected via a double lumen catheter in the femoral vein.
The investigators aim to verify whether using the DeCap) the investigators will be able to
avoid at the end of the T-piece trial the criteria of failure. If so, the patient will be
extubated and DeCap will be continued when all of the following were achieved for at least
12 hours: respiratory rate less than 25 breaths/min; pH greater than 7.35; Paco2 less than
20% of the baseline value; and absence of use of the accessory muscles or paradoxical
abdominal movements.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment