Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal

NCT02259335 | Unknown

• 1 other identifier: 110/2014
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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

Conditions

Patients With Acute Hypercapnic Respiratory Failure

Keywords

weaning from mechanical ventilation; extracorporeal CO2 removal; post-extubation failure

Outcome Measures

Primary Outcomes (2)

• passing a weaning trial using a T-piece method

  avoiding to reach the criteria of weaning failure

  1 hour

• weaning success

  avoiding reintubation after removal of DeCap

  48 hours

Secondary Outcomes (1)

• Physiological variables (i.e. Arterial Blood Gases, vitals and dyspnea)

  48 hours

Study Arms (1)

patients under invasive ventilation

EXPERIMENTAL

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

Interventions

Extracorporeal CO2 removal device 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

Also known as: DeCap

patients under invasive ventilation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients NOT meeting the criteria for readiness to be weaned
• Patients succeeding a T-piece trial

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• University of Turin, Italy: collaborator

Study Sites (2)

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

Turin, Turin, 10126, Italy

RECRUITING

San'Orsola Malpighi Hospital, Bologna ITALY

Bologna, 40138, Italy

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Respiratory Medicine

Study Record Dates

• First Submitted: October 4, 2014
• First Posted: October 8, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 11, 2016

Record last verified: 2016-10

Locations

IT (2)