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

Recruiting
18 years of age
Both
Phase N/A

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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:

  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

Study details

COPD Exacerbation Acute

NCT04881409

University of Leipzig

25 January 2024

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