Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal

Not Applicable

• Conditions: Patients With Acute Hypercapnic Respiratory Failure
• Interventions: Device: Extracorporeal CO2 removal device

• Registration Number: NCT02259335
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-04
• Study First Submitted QC: 2014-10-07
• Study First Posted: 2014-10-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-08
• Last Update Posted: 2016-10-11
• Primary Completion: 2017-04
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients under invasive ventilation	Extracorporeal CO2 removal device	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

Primary Outcome Measures

Name	Time	Method
passing a weaning trial using a T-piece method	1 hour	avoiding to reach the criteria of weaning failure
weaning success	48 hours	avoiding reintubation after removal of DeCap

Secondary Outcome Measures

Name	Time	Method
Physiological variables (i.e. Arterial Blood Gases, vitals and dyspnea)	48 hours

Trial Locations

Locations (2)

San'Orsola Malpighi Hospital, Bologna ITALY; 🇮🇹 Bologna, Italy

AOU Città della Salute e della Scienza di Torino, Molinette Hospital; 🇮🇹 Turin, Italy