Extracorporeal CO2 Removal in Hypercapnic Patients

NCT02564406 | Completed

• 1 other identifier: 3785
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• number of patients who avoided endotracheal intubation

  60 days

Secondary Outcomes (5)

• Gas exchange homeostasis

  96 hrs

• Norepinephrine requirements

  30 days

• coagulation

  30 days

• Day 28 mortality

  28 days

• intra hospital mortality

  180 days

Study Arms (1)

hypercapnic patients

EXPERIMENTAL

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

Device: LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR

Interventions

LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR DEVICE

hypercapnic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Dept of Anesthesiology and Intensive Care

Rome, 00161, Italy

Location

Related Publications (2)

• 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.

  PMID: 23460154 BACKGROUND

• 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.

  PMID: 25230375 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea Morelli, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Associate professor

Study Record Dates

• First Submitted: September 26, 2015
• First Posted: September 30, 2015
• Study Start: January 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 22, 2016

Record last verified: 2016-07

Locations

IT (1)