Nasal High-flow Compared to Non-invasive Ventilation in Treatment of Acute Acidotic Hypercapnic Exacerbation of Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
720
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2021
CompletedStudy Start
First participant enrolled
May 6, 2021
CompletedFirst Posted
Study publicly available on registry
May 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2024
CompletedFebruary 9, 2022
February 1, 2022
2.8 years
April 28, 2021
February 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion with treatment failure of allocated respiratory support within 72 h after start of respiratory support.
Treatment failure defined as 1. intubation or 2. switch to another method of non-invasive ventilation or 3. death
start of treatment until 72 hours
Secondary Outcomes (9)
intubation within 72 hours (component of primary outcome)
start of treatment until 72 hours
proportion intubated within 7 calendar days after hospitalisation/randomization
start of treatment until 7 calender days after hospitalisation/randomization
Overall survival at day 28 and day 90
start of treatment until day 90 after start of treatment
(Invasive) ventilator-free days until day 28
start of treatment until day 28 after start of treatment
(Invasive) ventilator-free hours until the primary endpoint is reached or 72 hours, whichever comes first
start of treatment until maximum 72 hours after start of treatment
- +4 more secondary outcomes
Study Arms (2)
nasal high-flow
EXPERIMENTALPatient with AECOPD is treated with NHF.
non-invasive ventilation
ACTIVE COMPARATORPatient with AECOPD is treated with NIV
Interventions
Patient with AECOPD is treated with NHF.
Patient with AECOPD is treated with NIV.
Eligibility Criteria
You may qualify if:
- acute hypercapnic exacerbation of chronic obstructive pulmonary disease with pH \< 7.35
- pCO2 \> 45mmHg
- age ≥ 18 years
- written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
München-Klinik Bogenhausen
München, Bavaria, 81925, Germany
Klinikum Emden
Emden, Lower Saxony, 26721, Germany
Lungenklinik Hemer
Hemer, North Rhine-Westphalia, 58675, Germany
University Hospital Leipzig
Leipzig, Saxony, 04103, Germany
Sana Kliniken Ostholstein
Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany
Evangelische Lungenklinik
Berlin, 13125, Germany
Related Publications (1)
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.
PMID: 35012620DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Pneumology
Study Record Dates
First Submitted
April 28, 2021
First Posted
May 11, 2021
Study Start
May 6, 2021
Primary Completion
February 6, 2024
Study Completion
October 6, 2024
Last Updated
February 9, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- After publication of the major results
- Access Criteria
- After publication of the major results and upon reasonable request from researchers performing an individual patient data meta-analysis, individual patient data that underlie published results will be shared after de-identification. This requires approval by the local ethics committee of the researcher requesting the data along with public registration of the meta-analysis. The coordinating investigator will contact the data protection officer before de-identification to ensure a correct and actual implementation of this process. Summary statistics that go beyond the scope of published material will be made available to researchers for meta-analysis upon reasonable request and if the necessary data analysis is not unduly time-consuming. Together with publication of the main results, the trial protocol in full will be made publically available as well as the statistical analysis plan.
According to the recommendations on data sharing by the International Committee of Medical Journal Editors (ICMJE) data resulting from the ELVIS trial will be made available to the scientific community.