COPD Exacerbation Acute
Conditions
Keywords
nasal high-flow, non-invasive ventilation
Brief summary
The ELVIS study compares the nasal high-flow to non-invasive ventilation in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease.
Detailed description
The ELVIS study is a prospective, randomized, multi-centre open label trial following a non-inferiority design to compare the nasal high-flow (NHF) to non-invasive ventilation (NIV) in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease. Accoring to the randomization the patient is treated with NHF or NIV until discharge. A change of device is possible, if switch criteria are fulfiled OR need for intubation criteria are met before 72h (timepoint for primary endpoint).
Interventions
DEVICERespiratory support with non-invasive ventilation (NIV)
Patient with AECOPD is treated with NIV.
DEVICERespiratory support with nasal high-flow (NHF)
Patient with AECOPD is treated with NHF.
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomization to NHF or NIV
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. acute hypercapnic exacerbation of chronic obstructive pulmonary disease with pH \< 7.35 2. pCO2 \> 45mmHg 3. age ≥ 18 years 4. written informed consent
Exclusion criteria
1. immediate need for intubation (acc. to intubation criteria in this protocol) 2. pH \< 7.15 3. BMI ≥ 35 kg/m² 4. established home-NIV or home-CPAP 5. end-stage disease with DNI/DNR order 6. diseases that could influence the primary endpoint: e.g. acute heart infarction, cardiogenic lung edema, acute and massive lung embolism (hypertensive), chronic dialysis with metabolic acidosis, unstable rib fracture influencing ventilation, injury to the face prohibiting use of a face mask 7. acute disease that precludes participation in the trial 8. tracheotomized patients 9. psychological/mental or other inabilities to supply required informed consent 10. participation in other interventional trials 11. suspected lack of compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion with treatment failure of allocated respiratory support within 72 h after start of respiratory support. | start of treatment until 72 hours | Treatment failure defined as 1. intubation or 2. switch to another method of non-invasive ventilation or 3. death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| proportion intubated within 7 calendar days after hospitalisation/randomization | start of treatment until 7 calender days after hospitalisation/randomization | — |
| Overall survival at day 28 and day 90 | start of treatment until day 90 after start of treatment | — |
| (Invasive) ventilator-free days until day 28 | start of treatment until day 28 after start of treatment | — |
| (Invasive) ventilator-free hours until the primary endpoint is reached or 72 hours, whichever comes first | start of treatment until maximum 72 hours after start of treatment | — |
| intubation within 72 hours (component of primary outcome) | start of treatment until 72 hours | independent of whether or not responsible primary endpoint |
| Proportion requiring sedation | start of treatment until discharge or day 90 after start of treatment (whichever comes first) | — |
| switch to another method of non-invasive ventilation within 72 hours (component of primary outcome) | start of treatment until 72 hours | independent of whether or not responsible primary endpoint |
| death within 72 hours (component of primary outcome) | start of treatment until 72 hours | independent of whether or not responsible primary endpoint |
| Intensive care unit (ICU) and hospital lengths of stay | start of treatment until discharge or day 90 after start of treatment (whichever comes first) | — |
Countries
Germany
Contacts
Primary ContactHubert Wirtz
Backup ContactNicole Köppe-Bauernfeind
Outcome results
None listed