Pulmonary Disease, Chronic ObstructiveNCT02564406
Extracorporeal CO2 Removal in Hypercapnic Patients
A study testing LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR in people with Pulmonary Disease, Chronic Obstructive, run by University of Roma La Sapienza at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- exacerbation of chronic obstructive pulmonary disease
- failure of non invasive ventilation
- expression of a clear intention not to be intubated
Who cannot join
- alterations in mental status which do not allow to express a clear intention not to be intubated
- contraindications to anticoagulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extracorporeal CO2 Removal in Hypercapnic Patients Who Failed Noninvasive Ventilation and Refuse Endotracheal Intubation: a Case Series
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTORDevice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who avoided endotracheal intubation
Measured: 60 days
Secondary outcomes (5)
Gas exchange homeostasis
pH, PaCO2, PaO2, bicarbonate, arterial lactate
Measured: 96 hrs
Norepinephrine requirements
norepinephrine requirements in the patients who due to clinical conditions were under norepinephrine before starting the treatment with extracorporeal Co2 removal
Measured: 30 days
coagulation
INR, pt, ptt. platelets
Measured: 30 days
Day 28 mortality
Measured: 28 days
intra hospital mortality
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startJan 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Morelli, University of Roma La Sapienza
- Investigators
- Andrea Morelli, MD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564406
- Sponsor's protocol ID
- 3785
- Status last verified
- Jul 2016
- First submitted
- 26 Sep 2015
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23460154Del 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.
PubMed 25230375
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal CO2 Removal in Hypercapnic Patients Who Failed Noninvasive Ventilation and Refuse Endotracheal Intubation: a Case Series
- ClinicalTrials.gov ID
- NCT02564406
- Acronym / sponsor ID
- 3785
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypercapnic patients | Experimental | Device: LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTORpatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- exacerbation of chronic obstructive pulmonary disease
- failure of non invasive ventilation
- expression of a clear intention not to be intubated
Key exclusion criteria (2 listed)
- alterations in mental status which do not allow to express a clear intention not to be intubated
- contraindications to anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR | Device | hypercapnic patients |
Primary outcome
number of patients who avoided endotracheal intubation
Time frame: 60 days
5 secondary outcomes
Gas exchange homeostasis
Time frame: 96 hrs
Norepinephrine requirements
Time frame: 30 days
coagulation
Time frame: 30 days
Day 28 mortality
Time frame: 28 days
intra hospital mortality
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
- Background: PubMed 23460154Burki 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.
- Background: PubMed 25230375Del 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Morelli, MD principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR in people with Pulmonary Disease, Chronic Obstructive, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients who avoided endotracheal intubation (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02564406, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2016.