Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal (WeanPRO)

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

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

Study Overview

• Status: Unknown
• Conditions: Patients With Acute Hypercapnic Respiratory Failure
• Intervention / Treatment: Device: Extracorporeal CO2 removal device

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • san'Orsola Malpighi Hospital, Bologna ITALY
    • Principal Investigator: Lara Pisani, MD
    • Principal Investigator: Luca Fasano, MD
    • Principal Investigator: Nadia Corcione, MD
  • Turin, Italy, 10126
    • Recruiting
    • AOU Città della Salute e della Scienza di Torino, Molinette Hospital
    • Contact: Marco V Ranieri, MD; Phone Number: 5500 011633; Email: marco.ranieri@unito.it
    • Principal Investigator: Vito Fanelli, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: DeCap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Physiological variables (i.e. Arterial Blood Gases, vitals and dyspnea)	48 hours

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Collaborators: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (ANTICIPATED): April 1, 2017
• Study Completion (ANTICIPATED): October 1, 2017

Study Registration Dates

• First Submitted: October 4, 2014
• First Submitted That Met QC Criteria: October 7, 2014
• First Posted (ESTIMATE): October 8, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 11, 2016
• Last Update Submitted That Met QC Criteria: October 8, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: extracorporeal CO2 removal; weaning from mechanical ventilation; post-extubation failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 110/2014