Nasal High-flow Compared to Non-invasive Ventilation in Treatment of Acute Acidotic Hypercapnic Exacerbation of Chronic Obstructive Pulmonary Disease

  • End date
    Oct 6, 2024
  • participants needed
  • sponsor
    University of Leipzig
Updated on 26 March 2022


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).

Condition COPD Exacerbation Acute
Treatment Respiratory support with nasal high-flow (NHF), Respiratory support with non-invasive ventilation (NIV)
Clinical Study IdentifierNCT04881409
SponsorUniversity of Leipzig
Last Modified on26 March 2022


Yes No Not Sure

Inclusion Criteria

acute hypercapnic exacerbation of chronic obstructive pulmonary disease with pH < 7.35
pCO2 > 45mmHg
age ≥ 18 years
written informed consent

Exclusion Criteria

immediate need for intubation (acc. to intubation criteria in this protocol)
pH < 7.15
BMI ≥ 35 kg/m²
established home-NIV or home-CPAP
end-stage disease with DNI/DNR order
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
acute disease that precludes participation in the trial
tracheotomized patients
psychological/mental or other inabilities to supply required informed consent
participation in other interventional trials
suspected lack of compliance
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