Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal (WeanPRO)
Primary Purpose
Patients With Acute Hypercapnic Respiratory Failure
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Extracorporeal CO2 removal device
Sponsored by
About this trial
This is an interventional treatment trial for Patients With Acute Hypercapnic Respiratory Failure focused on measuring weaning from mechanical ventilation, extracorporeal CO2 removal, post-extubation failure
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
Sites / Locations
- San'Orsola Malpighi Hospital, Bologna ITALYRecruiting
- AOU Città della Salute e della Scienza di Torino, Molinette HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients under invasive ventilation
Arm Description
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
Outcomes
Primary Outcome Measures
passing a weaning trial using a T-piece method
avoiding to reach the criteria of weaning failure
weaning success
avoiding reintubation after removal of DeCap
Secondary Outcome Measures
Physiological variables (i.e. Arterial Blood Gases, vitals and dyspnea)
Full Information
NCT ID
NCT02259335
First Posted
October 4, 2014
Last Updated
October 8, 2016
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT02259335
Brief Title
Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal
Acronym
WeanPRO
Official Title
A Pilot Study on the Use of Extracorporeal CO2 Removal During the Weaning Process From Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
University of Turin, Italy
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Acute Hypercapnic Respiratory Failure
Keywords
weaning from mechanical ventilation, extracorporeal CO2 removal, post-extubation failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients under invasive ventilation
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Extracorporeal CO2 removal device
Other Intervention Name(s)
DeCap
Intervention Description
A device able to remove CO2 using a dedicated device connected to the patient via a double lumen catheter inserted in the femoral vein
Primary Outcome Measure Information:
Title
passing a weaning trial using a T-piece method
Description
avoiding to reach the criteria of weaning failure
Time Frame
1 hour
Title
weaning success
Description
avoiding reintubation after removal of DeCap
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Physiological variables (i.e. Arterial Blood Gases, vitals and dyspnea)
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
San'Orsola Malpighi Hospital, Bologna ITALY
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Nava, MD
Phone
051 6364017
Email
stefano.nava@aosp.bo.it
First Name & Middle Initial & Last Name & Degree
Stefano Nava, MD
First Name & Middle Initial & Last Name & Degree
Lara Pisani, MD
First Name & Middle Initial & Last Name & Degree
Luca Fasano, MD
First Name & Middle Initial & Last Name & Degree
Nadia Corcione, MD
Facility Name
AOU Città della Salute e della Scienza di Torino, Molinette Hospital
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco V Ranieri, MD
Phone
011633
Ext
5500
Email
marco.ranieri@unito.it
First Name & Middle Initial & Last Name & Degree
Vito Fanelli, MD, PhD
12. IPD Sharing Statement
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Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal
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