Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal (WeanPRO)
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|ClinicalTrials.gov Identifier: NCT02259335|
Recruitment Status : Unknown
Verified October 2016 by dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.
Recruitment status was: Recruiting
First Posted : October 8, 2014
Last Update Posted : October 11, 2016
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
|Condition or disease||Intervention/treatment||Phase|
|Patients With Acute Hypercapnic Respiratory Failure||Device: Extracorporeal CO2 removal device||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study on the Use of Extracorporeal CO2 Removal During the Weaning Process From Mechanical Ventilation|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||October 2017|
Experimental: 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
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
Other Name: DeCap
- passing a weaning trial using a T-piece method [ Time Frame: 1 hour ]avoiding to reach the criteria of weaning failure
- weaning success [ Time Frame: 48 hours ]avoiding reintubation after removal of DeCap
- Physiological variables (i.e. Arterial Blood Gases, vitals and dyspnea) [ Time Frame: 48 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259335
|San'Orsola Malpighi Hospital, Bologna ITALY||Recruiting|
|Bologna, Italy, 40138|
|Contact: Stefano Nava, MD 051 6364017 email@example.com|
|Principal Investigator: Stefano Nava, MD|
|Principal Investigator: Lara Pisani, MD|
|Principal Investigator: Luca Fasano, MD|
|Principal Investigator: Nadia Corcione, MD|
|AOU Città della Salute e della Scienza di Torino, Molinette Hospital||Recruiting|
|Turin, Italy, 10126|
|Contact: Marco V Ranieri, MD 011633 ext 5500 firstname.lastname@example.org|
|Principal Investigator: Vito Fanelli, MD, PhD|