Overview
The ELVIS study compares the nasal high-flow to non-invasive ventilation in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease.
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).
Eligibility
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