Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study on the Use of Extracorporeal CO2 Removal During the Weaning Process From Mechanical Ventilation

Conditions
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Patients With Acute Hypercapnic Respiratory Failure

Intervention / Treatment
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* Device: Extracorporeal CO2 removal device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients under invasive ventilation<br>those patients failing a T-piece trial beacuse of a PaCO2 rise>20% of baseline and/or a rapid shallow-breathing index >100 will be reconnected to the ventilator Two hours later they will repeat a T-piece trial after connection to the CO2 removal device | Device: Extracorporeal CO2 removal device<br>* A device able to remove CO2 using a dedicated device connected to the patient via a double lumen catheter inserted in the femoral vein<br>* Other names: DeCap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| passing a weaning trial using a T-piece method | avoiding to reach the criteria of weaning failure | 1 hour | 
| weaning success | avoiding reintubation after removal of DeCap | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological variables (i.e. Arterial Blood Gases, vitals and dyspnea) |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weaning from mechanical ventilation, extracorporeal CO2 removal, post-extubation failure