Nasal High-flow Compared to Non-invasive Ventilation in Treatment of Acute Acidotic Hypercapnic Exacerbation of Chronic Obstructive Pulmonary Disease
NCT ID: NCT04881409
Last Updated: 2022-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
720 participants
INTERVENTIONAL
2021-05-06
2024-10-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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nasal high-flow
Patient with AECOPD is treated with NHF.
Respiratory support with nasal high-flow (NHF)
Patient with AECOPD is treated with NHF.
non-invasive ventilation
Patient with AECOPD is treated with NIV
Respiratory support with non-invasive ventilation (NIV)
Patient with AECOPD is treated with NIV.
Interventions
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Respiratory support with nasal high-flow (NHF)
Patient with AECOPD is treated with NHF.
Respiratory support with non-invasive ventilation (NIV)
Patient with AECOPD is treated with NIV.
Eligibility Criteria
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Inclusion Criteria
2. pCO2 \> 45mmHg
3. age ≥ 18 years
4. written informed consent
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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University of Leipzig
OTHER
Responsible Party
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Hubert Wirtz
Head of Pneumology
Locations
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München-Klinik Bogenhausen
München, Bavaria, Germany
Klinikum Emden
Emden, Lower Saxony, Germany
Lungenklinik Hemer
Hemer, North Rhine-Westphalia, Germany
University Hospital Leipzig
Leipzig, Saxony, Germany
Sana Kliniken Ostholstein
Oldenburg in Holstein, Schleswig-Holstein, Germany
Evangelische Lungenklinik
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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ELVIS
Identifier Type: -
Identifier Source: org_study_id
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