Clinical trial NCT02564406: Extracorporeal CO2 Removal in Hypercapnic Patients
Official title: Extracorporeal CO2 Removal in Hypercapnic Patients Who Failed Noninvasive Ventilation and Refuse Endotracheal Intubation: a Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of patients who avoided endotracheal intubation
timeFrame: 60 days
Secondary outcomes:
measure: Gas exchange homeostasis
timeFrame: 96 hrs
measure: Norepinephrine requirements
timeFrame: 30 days
measure: coagulation
timeFrame: 30 days
measure: Day 28 mortality
timeFrame: 28 days
measure: intra hospital mortality
timeFrame: 180 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Dept of Anesthesiology and Intensive Care
Study officials:
affiliation: University of Roma La Sapienza
name: Andrea Morelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burki NK, Mani RK, Herth FJF, Schmidt W, Teschler H, Bonin F, Becker H, Randerath WJ, Stieglitz S, Hagmeyer L, Priegnitz C, Pfeifer M, Blaas SH, Putensen C, Theuerkauf N, Quintel M, Moerer O. A novel extracorporeal CO(2) removal system: results of a pilot study of hypercapnic respiratory failure in patients with COPD. Chest. 2013 Mar;143(3):678-686. doi: 10.1378/chest.12-0228.
citation: Del Sorbo L, Pisani L, Filippini C, Fanelli V, Fasano L, Terragni P, Dell'Amore A, Urbino R, Mascia L, Evangelista A, Antro C, D'Amato R, Sucre MJ, Simonetti U, Persico P, Nava S, Ranieri VM. Extracorporeal Co2 removal in hypercapnic patients at risk of noninvasive ventilation failure: a matched cohort study with historical control. Crit Care Med. 2015 Jan;43(1):120-7. doi: 10.1097/CCM.0000000000000607.