Status:
UNKNOWN
Nasal High-flow Compared to Non-invasive Ventilation in Treatment of Acute Acidotic Hypercapnic Exacerbation of Chronic Obstructive Pulmonary Disease
Lead Sponsor:
University of Leipzig
Conditions:
COPD Exacerbation Acute
Eligibility:
All Genders
18+ years
Phase:
NA
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 ac...
Eligibility Criteria
Inclusion
- acute hypercapnic exacerbation of chronic obstructive pulmonary disease with pH \< 7.35
- pCO2 \> 45mmHg
- age ≥ 18 years
- written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 6 2024
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT04881409
Start Date
May 6 2021
End Date
October 6 2024
Last Update
February 9 2022
Active Locations (6)
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1
München-Klinik Bogenhausen
München, Bavaria, Germany, 81925
2
Klinikum Emden
Emden, Lower Saxony, Germany, 26721
3
Lungenklinik Hemer
Hemer, North Rhine-Westphalia, Germany, 58675
4
University Hospital Leipzig
Leipzig, Saxony, Germany, 04103