Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal

NCT ID: NCT02259335

Last Updated: 2016-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-10-31

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.

Conditions

Patients With Acute Hypercapnic Respiratory Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients under invasive ventilation

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

Group Type: EXPERIMENTAL

Extracorporeal CO2 removal device

Intervention Type: DEVICE

A device able to remove CO2 using a dedicated device connected to the patient via a double lumen catheter inserted in the femoral vein

Interventions

Extracorporeal CO2 removal device

A device able to remove CO2 using a dedicated device connected to the patient via a double lumen catheter inserted in the femoral vein

Intervention Type: DEVICE

Other Intervention Names

DeCap

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

dr. Stefano Nava

Professor of Respiratory Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AOU Città della Salute e della Scienza di Torino, Molinette Hospital

Turin, Turin, Italy

Site Status: RECRUITING

San'Orsola Malpighi Hospital, Bologna ITALY

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Marco V Ranieri, MD

Role: primary

marco.ranieri@unito.it

011633 ext. 5500

Stefano Nava, MD

Role: primary

stefano.nava@aosp.bo.it

051 6364017

Other Identifiers

110/2014

Identifier Type: -

Identifier Source: org_study_id