Extracorporeal CO2 Removal in Hypercapnic Patients

NCT ID: NCT02564406

Last Updated: 2016-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hypercapnic patients

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

Group Type EXPERIMENTAL

LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR

Intervention Type DEVICE

Interventions

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LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Andrea Morelli

MD. Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Morelli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

Locations

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Dept of Anesthesiology and Intensive Care

Rome, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 23460154 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25230375 (View on PubMed)

Other Identifiers

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3785

Identifier Type: -

Identifier Source: org_study_id

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