Clinical trial NCT04881409: Nasal High-flow Compared to Non-invasive Ventilation in Treatment of Acute Acidotic Hypercapnic Exacerbation of Chronic Obstructive Pulmonary Disease
Official title: Nasal High-flow Compared to Non-invasive Ventilation in Treatment of Acute Acidotic Hypercapnic Exacerbation of Chronic Obstructive Pulmonary Disease - a Randomized Controlled Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD Exacerbation Acute
Keywords: nasal high-flow
non-invasive ventilation
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomization to NHF or NIV
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Proportion with treatment failure of allocated respiratory support within 72 h after start of respiratory support.
timeFrame: start of treatment until 72 hours
Secondary outcomes:
measure: intubation within 72 hours (component of primary outcome)
timeFrame: start of treatment until 72 hours
measure: proportion intubated within 7 calendar days after hospitalisation/randomization
timeFrame: start of treatment until 7 calender days after hospitalisation/randomization
measure: Overall survival at day 28 and day 90
timeFrame: start of treatment until day 90 after start of treatment
measure: (Invasive) ventilator-free days until day 28
timeFrame: start of treatment until day 28 after start of treatment
measure: (Invasive) ventilator-free hours until the primary endpoint is reached or 72 hours, whichever comes first
timeFrame: start of treatment until maximum 72 hours after start of treatment
measure: Intensive care unit (ICU) and hospital lengths of stay
timeFrame: start of treatment until discharge or day 90 after start of treatment (whichever comes first)
measure: Proportion requiring sedation
timeFrame: start of treatment until discharge or day 90 after start of treatment (whichever comes first)
measure: switch to another method of non-invasive ventilation within 72 hours (component of primary outcome)
timeFrame: start of treatment until 72 hours
measure: death within 72 hours (component of primary outcome)
timeFrame: start of treatment until 72 hours
Other outcomes:
Locations:
city: München
country: Germany
facility: München-Klinik Bogenhausen
state: Bavaria
city: Emden
country: Germany
facility: Klinikum Emden
state: Lower Saxony
city: Hemer
country: Germany
facility: Lungenklinik Hemer
state: North Rhine-Westphalia
city: Leipzig
country: Germany
facility: University Hospital Leipzig
state: Saxonia
city: Oldenburg In Holstein
country: Germany
facility: Sana Kliniken Ostholstein
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Evangelische Lungenklinik
Study officials:
References:
citation: Braunlich J, Koppe-Bauernfeind N, Petroff D, Franke A, Wirtz H. Nasal high-flow compared to non-invasive ventilation in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease-protocol for a randomized controlled noninferiority trial (ELVIS). Trials. 2022 Jan 10;23(1):28. doi: 10.1186/s13063-021-05978-z.