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Trial record 71 of 683 for:    CARBON DIOXIDE AND arterial

Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal (WeanPRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
University of Turin, Italy
Information provided by (Responsible Party):
dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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


Condition or disease Intervention/treatment Phase
Patients With Acute Hypercapnic Respiratory Failure Device: Extracorporeal CO2 removal device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. passing a weaning trial using a T-piece method [ Time Frame: 1 hour ]
    avoiding to reach the criteria of weaning failure

  2. weaning success [ Time Frame: 48 hours ]
    avoiding reintubation after removal of DeCap


Secondary Outcome Measures :
  1. Physiological variables (i.e. Arterial Blood Gases, vitals and dyspnea) [ Time Frame: 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Italy
San'Orsola Malpighi Hospital, Bologna ITALY Recruiting
Bologna, Italy, 40138
Contact: Stefano Nava, MD    051 6364017    stefano.nava@aosp.bo.it   
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    marco.ranieri@unito.it   
Principal Investigator: Vito Fanelli, MD, PhD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
University of Turin, Italy

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Responsible Party: dr. Stefano Nava, Professor of Respiratory Medicine, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT02259335    
Other Study ID Numbers: 110/2014
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Keywords provided by dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
weaning from mechanical ventilation
extracorporeal CO2 removal
post-extubation failure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases