COPD Exacerbation AcuteNCT04881409
Nasal High-flow Compared to Non-invasive Ventilation in Treatment of Acute Acidotic Hypercapnic Exacerbation of Chronic Obstructive Pulmonary Disease
A study testing Respiratory support with nasal high-flow (NHF) and Respiratory support with non-invasive ventilation (NIV) in people with COPD Exacerbation Acute, run by University of Leipzig at 6 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation Acute
- What is being tested?
- Respiratory support with nasal high-flow (NHF) and Respiratory support with non-invasive ventilation (NIV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 6 sitesGermany
- Study dates
- 6 May 2021to 6 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute hypercapnic exacerbation of chronic obstructive pulmonary disease with pH < 7.35
- pCO2 > 45mmHg
- age ≥ 18 years
- written informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Recruiting
Evangelische Lungenklinik
Berlin, 13125
Christian Grohé, Prof., 004930 94802112, christian.grohe@jsd.de
- Recruiting
Klinikum Emden
Emden, Lower Saxony, 26721
Jens Bräunlich, PD Dr., 00494921981598, j.braeunlich@klinikum-emden.de
- Recruiting
Lungenklinik Hemer
Hemer, North Rhine-Westphalia, 58675
Michael Westhoff, Dr., 004923729082201, michael.westhoff@lkhemer.de
- Recruiting
University Hospital Leipzig
Leipzig, Saxony, 04103
Hubert Wirtz, Prof., 00493419712600, hubert.wirtz@medizin.uni-leipzig.de
- Recruiting
München-Klinik Bogenhausen
München, Bavaria, 81925
Christoph Dodt, Prof., 0049 899270707549, christoph.dodt@muenchen-klinik.de
- Recruiting
Sana Kliniken Ostholstein
Oldenburg in Holstein, Schleswig-Holstein, 23758
Iris Koper, Dr., 00494361513140, iris.koper@sana.de
About this study
Official title: Nasal High-flow Compared to Non-invasive Ventilation in Treatment of Acute Acidotic Hypercapnic Exacerbation of Chronic Obstructive Pulmonary Disease - a Randomized Controlled Noninferiority Trial
The ELVIS study compares the nasal high-flow to non-invasive ventilation in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease.
Read the 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 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).
- Conditions
- COPD Exacerbation Acute
- Being tested
- Respiratory support with nasal high-flow (NHF), Respiratory support with non-invasive ventilation (NIV)
- Keywords
- nasal high-flow, non-invasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory support with nasal high-flow (NHF)Device
Patient with AECOPD is treated with NHF.
Respiratory support with non-invasive ventilation (NIV)Device
Patient with AECOPD is treated with NIV.
| Study group | Role | What they receive |
|---|---|---|
| nasal high-flow | Experimental | Patient with AECOPD is treated with NHF. Receives: Device: Respiratory support with nasal high-flow (NHF) |
| non-invasive ventilation | Active comparator | Patient with AECOPD is treated with NIV Receives: Device: Respiratory support with non-invasive ventilation (NIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion with treatment failure of allocated respiratory support within 72 h after start of respiratory support.
Treatment failure defined as
- intubation or
- switch to another method of non-invasive ventilation or
- death
Measured: start of treatment until 72 hours
Secondary outcomes (9)
intubation within 72 hours (component of primary outcome)
independent of whether or not responsible primary endpoint
Measured: start of treatment until 72 hours
proportion intubated within 7 calendar days after hospitalisation/randomization
Measured: start of treatment until 7 calender days after hospitalisation/randomization
Overall survival at day 28 and day 90
Measured: start of treatment until day 90 after start of treatment
(Invasive) ventilator-free days until day 28
Measured: 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
Measured: start of treatment until maximum 72 hours after start of treatment
Intensive care unit (ICU) and hospital lengths of stay
Measured: start of treatment until discharge or day 90 after start of treatment (whichever comes first)
Proportion requiring sedation
Measured: start of treatment until discharge or day 90 after start of treatment (whichever comes first)
switch to another method of non-invasive ventilation within 72 hours (component of primary outcome)
independent of whether or not responsible primary endpoint
Measured: start of treatment until 72 hours
death within 72 hours (component of primary outcome)
independent of whether or not responsible primary endpoint
Measured: start of treatment until 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start6 May 2021
- Primary completion6 Feb 2024 (estimated)
- Study completion6 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD Exacerbation AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomization to NHF or NIV
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hubert Wirtz, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881409
- Sponsor's protocol ID
- ELVIS
- Status last verified
- Feb 2022
- First submitted
- 28 Apr 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35012620
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal High-flow Compared to Non-invasive Ventilation in Treatment of Acute Acidotic Hypercapnic Exacerbation of Chronic Obstructive Pulmonary Disease - a Randomized Controlled Noninferiority Trial
- ClinicalTrials.gov ID
- NCT04881409
- Acronym / sponsor ID
- ELVIS
- Conditions
- COPD Exacerbation Acute
- Keywords
- nasal high-flow, non-invasive ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 6 Feb 2024 (estimated)
- Study completion
- 6 Oct 2024 (estimated)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomization to NHF or NIV
| Arm | Type | Receives |
|---|---|---|
| nasal high-flow | Experimental | Device: Respiratory support with nasal high-flow (NHF)Patient with AECOPD is treated with NHF. |
| non-invasive ventilation | Active comparator | Device: Respiratory support with non-invasive ventilation (NIV)Patient with AECOPD is treated with NIV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- acute hypercapnic exacerbation of chronic obstructive pulmonary disease with pH < 7.35
- pCO2 > 45mmHg
- age ≥ 18 years
- written informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory support with nasal high-flow (NHF)Patient with AECOPD is treated with NHF. | Device | nasal high-flow |
| Respiratory support with non-invasive ventilation (NIV)Patient with AECOPD is treated with NIV. | Device | non-invasive ventilation |
Primary outcome
Proportion with treatment failure of allocated respiratory support within 72 h after start of respiratory support.
Time frame: start of treatment until 72 hours
Treatment failure defined as 1. intubation or 2. switch to another method of non-invasive ventilation or 3. death
9 secondary outcomes
intubation within 72 hours (component of primary outcome)
Time frame: start of treatment until 72 hours
proportion intubated within 7 calendar days after hospitalisation/randomization
Time frame: start of treatment until 7 calender days after hospitalisation/randomization
Overall survival at day 28 and day 90
Time frame: start of treatment until day 90 after start of treatment
(Invasive) ventilator-free days until day 28
Time frame: 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
Time frame: start of treatment until maximum 72 hours after start of treatment
Intensive care unit (ICU) and hospital lengths of stay
Time frame: start of treatment until discharge or day 90 after start of treatment (whichever comes first)
Proportion requiring sedation
Time frame: start of treatment until discharge or day 90 after start of treatment (whichever comes first)
switch to another method of non-invasive ventilation within 72 hours (component of primary outcome)
Time frame: start of treatment until 72 hours
death within 72 hours (component of primary outcome)
Time frame: start of treatment until 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Derived from this study: PubMed 35012620Braunlich 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory support with nasal high-flow (NHF) and Respiratory support with non-invasive ventilation (NIV) in people with COPD Exacerbation Acute, run by University of Leipzig at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hubert Wirtz (00493419712601, hubert.wirtz@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion with treatment failure of allocated respiratory support within 72 h after start of respiratory support. (time frame: start of treatment until 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04881409, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.