Pulmonary Disease, Chronic Obstructive
Conditions
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.
Interventions
DEVICELOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR
Sponsors
University of Roma La Sapienza
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of patients who avoided endotracheal intubation | 60 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gas exchange homeostasis | 96 hrs | pH, PaCO2, PaO2, bicarbonate, arterial lactate |
| Norepinephrine requirements | 30 days | norepinephrine requirements in the patients who due to clinical conditions were under norepinephrine before starting the treatment with extracorporeal Co2 removal |
| coagulation | 30 days | INR, pt, ptt. platelets |
| Day 28 mortality | 28 days | — |
| intra hospital mortality | 180 days | — |
Countries
Italy
Outcome results
None listed