Extracorporeal CO2 Removal in Hypercapnic Patients
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
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
Sites / Locations
- Dept of Anesthesiology and Intensive Care
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hypercapnic patients
Arm Description
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
Outcomes
Primary Outcome Measures
number of patients who avoided endotracheal intubation
Secondary Outcome Measures
Gas exchange homeostasis
pH, PaCO2, PaO2, bicarbonate, arterial lactate
Norepinephrine requirements
norepinephrine requirements in the patients who due to clinical conditions were under norepinephrine before starting the treatment with extracorporeal Co2 removal
coagulation
INR, pt, ptt. platelets
Day 28 mortality
intra hospital mortality
Full Information
NCT ID
NCT02564406
First Posted
September 26, 2015
Last Updated
July 21, 2016
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT02564406
Brief Title
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
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hypercapnic patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR
Primary Outcome Measure Information:
Title
number of patients who avoided endotracheal intubation
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Gas exchange homeostasis
Description
pH, PaCO2, PaO2, bicarbonate, arterial lactate
Time Frame
96 hrs
Title
Norepinephrine requirements
Description
norepinephrine requirements in the patients who due to clinical conditions were under norepinephrine before starting the treatment with extracorporeal Co2 removal
Time Frame
30 days
Title
coagulation
Description
INR, pt, ptt. platelets
Time Frame
30 days
Title
Day 28 mortality
Time Frame
28 days
Title
intra hospital mortality
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Morelli, MD
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Anesthesiology and Intensive Care
City
Rome
ZIP/Postal Code
00161
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
23460154
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.
Results Reference
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PubMed Identifier
25230375
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.
Results Reference
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Extracorporeal CO2 Removal in Hypercapnic Patients
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