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

University of Leipzig

Status: Enrolling

Conditions: COPD Exacerbation Acute

Treatments: Device: Respiratory support with non-invasive ventilation (NIV); Device: Respiratory support with nasal high-flow (NHF)

Study type: Interventional

Funder types: Other

Identifiers

NCT04881409

ELVIS

Details and patient eligibility

About

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

Full 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).

Enrollment: 720 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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720 participants in 2 patient groups

nasal high-flow

Experimental group

Description:

Patient with AECOPD is treated with NHF.

Treatment:

Device: Respiratory support with nasal high-flow (NHF)

non-invasive ventilation

Active Comparator group

Description:

Patient with AECOPD is treated with NIV

Treatment:

Device: Respiratory support with non-invasive ventilation (NIV)