The ELVIS study compares the nasal high-flow to non-invasive ventilation in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
720
Patient with AECOPD is treated with NHF.
Patient with AECOPD is treated with NIV.
München-Klinik Bogenhausen
München, Bavaria, Germany
RECRUITINGKlinikum Emden
Emden, Lower Saxony, Germany
RECRUITINGLungenklinik Hemer
Hemer, North Rhine-Westphalia, Germany
Proportion with treatment failure of allocated respiratory support within 72 h after start of respiratory support.
Treatment failure defined as 1. intubation or 2. switch to another method of non-invasive ventilation or 3. death
Time frame: start of treatment until 72 hours
intubation within 72 hours (component of primary outcome)
independent of whether or not responsible primary endpoint
Time frame: start of treatment until 72 hours
proportion intubated within 7 calendar days after hospitalisation/randomization
Time frame: start of treatment until 7 calender days after hospitalisation/randomization
Overall survival at day 28 and day 90
Time frame: start of treatment until day 90 after start of treatment
(Invasive) ventilator-free days until day 28
Time frame: 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
Time frame: start of treatment until maximum 72 hours after start of treatment
Intensive care unit (ICU) and hospital lengths of stay
Time frame: start of treatment until discharge or day 90 after start of treatment (whichever comes first)
Proportion requiring sedation
Time frame: start of treatment until discharge or day 90 after start of treatment (whichever comes first)
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University Hospital Leipzig
Leipzig, Saxony, Germany
RECRUITINGSana Kliniken Ostholstein
Oldenburg in Holstein, Schleswig-Holstein, Germany
RECRUITINGEvangelische Lungenklinik
Berlin, Germany
RECRUITINGswitch to another method of non-invasive ventilation within 72 hours (component of primary outcome)
independent of whether or not responsible primary endpoint
Time frame: start of treatment until 72 hours
death within 72 hours (component of primary outcome)
independent of whether or not responsible primary endpoint
Time frame: start of treatment until 72 hours