Clinical trial NCT02259335: Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal
Official title: A Pilot Study on the Use of Extracorporeal CO2 Removal During the Weaning Process From Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With Acute Hypercapnic Respiratory Failure
Keywords: weaning from mechanical ventilation
extracorporeal CO2 removal
post-extubation failure
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
Collaborators: name: University of Turin, Italy
First posted: 2014-10-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients meeting the criteria for readiness to be weaned (i.e. clinical stability, FiO2\<50%, normal sensorium, body temperature \< 38 and satisfactory cough reflex)
* Failing a T-piece trial after 1 hour or before for a rise in PaCO2\>20% from baseline and with f/VT ratio \>100

Exclusion Criteria:

* Patients NOT meeting the criteria for readiness to be weaned
* Patients succeeding a T-piece trial

Primary outcomes:
measure: passing a weaning trial using a T-piece method
timeFrame: 1 hour
measure: weaning success
timeFrame: 48 hours
Secondary outcomes:
measure: Physiological variables (i.e. Arterial Blood Gases, vitals and dyspnea)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: San'Orsola Malpighi Hospital, Bologna ITALY
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza di Torino, Molinette Hospital
Study officials:
References: