Extracorporeal CO2 Removal in Hypercapnic Patients

University of Roma La Sapienza

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Device: LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR

Study type: Interventional

Funder types: Other

Identifiers

NCT02564406

3785

Details and patient eligibility

About

Noninvasive ventilation represents the standard of care for patients with exacerbation of chronic obstructive pulmonary disease. However, NIV fails in almost 30% of the most severe forms of acute hypercapnic respiratory failure and patients must undergo endotracheal intubation and invasive ventilation to restore adequate gas exchange. Under these circumstances, patients may express a clear intention not to be intubated.The aim of this study is to retrospectively assess efficacy and safety of noninvasive ventilation- plus-extracorporeal Co2 removal in patients who fail NIV and refuse endotracheal intubation.

Full description

During a period of two years (from January 2013 to July 2015) 35 patients with acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease, refused endotracheal intubation after failing NIV and were treated with extracorporeal Co2 removal plus NIV as last resort therapy.

The collected data of these patients will be retrospectively matched with data obtained from 35 historical controls who received conventional treatment with endotracheal intubation. The study will retrospectively compare intubation rate, acid base homeostasis, norepinephrine requirements (in the patients who due to clinical conditions were under norepinephrine before starting extracorporeal Co2 removal ) and coagulation parameters.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• exacerbation of chronic obstructive pulmonary disease
• failure of non invasive ventilation
• expression of a clear intention not to be intubated

Exclusion criteria

• alterations in mental status which do not allow to express a clear intention not to be intubated
• contraindications to anticoagulation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

hypercapnic patients

Experimental group

Description:

patients with acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease, refused endotracheal intubation after failing NIV and were treated withLow flow etracorporeal CO2 removal

Treatment:

Device: LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR