Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal

Patients With Acute Hypercapnic Respiratory Failure Clinical Trial

— WeanPRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02259335
• Other study ID #: 110/2014
• Status: Recruiting
• Phase: N/A
• First received: October 4, 2014
• Last updated: October 8, 2016
• Start date: October 2014
• Est. completion date: October 2017

Study information

• Verified date: October 2016
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercapnia
• Patients With Acute Hypercapnic Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• 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

Locations

Country	Name	City	State
Italy	San'Orsola Malpighi Hospital, Bologna ITALY	Bologna
Italy	AOU Città della Salute e della Scienza di Torino, Molinette Hospital	Turin

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi	University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	passing a weaning trial using a T-piece method	avoiding to reach the criteria of weaning failure	1 hour	Yes
Primary	weaning success	avoiding reintubation after removal of DeCap	48 hours	Yes
Secondary	Physiological variables (i.e. Arterial Blood Gases, vitals and dyspnea)		48 hours	No