Extracorporeal CO2 Removal in Hypercapnic Patients

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Extracorporeal CO2 Removal in Hypercapnic Patients Who Failed Noninvasive Ventilation and Refuse Endotracheal Intubation: a Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564406
• Other study ID #: 3785
• Status: Completed
• Phase: N/A
• First received: September 26, 2015
• Last updated: July 21, 2016
• Start date: January 2013
• Est. completion date: September 2015

Study information

• Verified date: July 2016
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Hypercapnia
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR

Locations

Country	Name	City	State
Italy	Dept of Anesthesiology and Intensive Care	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Burki NK, Mani RK, Herth FJ, 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):678-86. doi: 10.1378/chest.12-0228. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients who avoided endotracheal intubation		60 days	No
Secondary	Gas exchange homeostasis	pH, PaCO2, PaO2, bicarbonate, arterial lactate	96 hrs	No
Secondary	Norepinephrine requirements	norepinephrine requirements in the patients who due to clinical conditions were under norepinephrine before starting the treatment with extracorporeal Co2 removal	30 days	No
Secondary	coagulation	INR, pt, ptt. platelets	30 days	No
Secondary	Day 28 mortality		28 days	No
Secondary	intra hospital mortality		180 days	No