Extracorporeal CO2 Removal in Hypercapnic Patients

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Device: LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR

• Registration Number: NCT02564406
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2015-09-26
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-21
• Last Update Posted: 2016-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hypercapnic patients	LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR	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

Primary Outcome Measures

Name	Time	Method
number of patients who avoided endotracheal intubation	60 days

Secondary Outcome Measures

Name	Time	Method
Gas exchange homeostasis	96 hrs	pH, PaCO2, PaO2, bicarbonate, arterial lactate
Norepinephrine requirements	30 days	norepinephrine requirements in the patients who due to clinical conditions were under norepinephrine before starting the treatment with extracorporeal Co2 removal
coagulation	30 days	INR, pt, ptt. platelets
Day 28 mortality	28 days
intra hospital mortality	180 days

Trial Locations

Locations (1)

Dept of Anesthesiology and Intensive Care; 🇮🇹 Rome, Italy