search
Back to results

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

Primary Purpose

COPD Exacerbation Acute

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Respiratory support with nasal high-flow (NHF)
Respiratory support with non-invasive ventilation (NIV)
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD Exacerbation Acute focused on measuring nasal high-flow, non-invasive ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • München-Klinik BogenhausenRecruiting
  • Klinikum EmdenRecruiting
  • Lungenklinik HemerRecruiting
  • University Hospital LeipzigRecruiting
  • Sana Kliniken OstholsteinRecruiting
  • Evangelische LungenklinikRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nasal high-flow

non-invasive ventilation

Arm Description

Patient with AECOPD is treated with NHF.

Patient with AECOPD is treated with NIV

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

intubation within 72 hours (component of primary outcome)
independent of whether or not responsible primary endpoint
proportion intubated within 7 calendar days after hospitalisation/randomization
Overall survival at day 28 and day 90
(Invasive) ventilator-free days until day 28
(Invasive) ventilator-free hours until the primary endpoint is reached or 72 hours, whichever comes first
Intensive care unit (ICU) and hospital lengths of stay
Proportion requiring sedation
switch to another method of non-invasive ventilation within 72 hours (component of primary outcome)
independent of whether or not responsible primary endpoint
death within 72 hours (component of primary outcome)
independent of whether or not responsible primary endpoint

Full Information

First Posted
April 28, 2021
Last Updated
February 8, 2022
Sponsor
University of Leipzig
search

1. Study Identification

Unique Protocol Identification Number
NCT04881409
Brief Title
Nasal High-flow Compared to Non-invasive Ventilation in Treatment of Acute Acidotic Hypercapnic Exacerbation of Chronic Obstructive Pulmonary Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
February 6, 2024 (Anticipated)
Study Completion Date
October 6, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation Acute
Keywords
nasal high-flow, non-invasive ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomization to NHF or NIV
Masking
None (Open Label)
Allocation
Randomized
Enrollment
720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nasal high-flow
Arm Type
Experimental
Arm Description
Patient with AECOPD is treated with NHF.
Arm Title
non-invasive ventilation
Arm Type
Active Comparator
Arm Description
Patient with AECOPD is treated with NIV
Intervention Type
Device
Intervention Name(s)
Respiratory support with nasal high-flow (NHF)
Intervention Description
Patient with AECOPD is treated with NHF.
Intervention Type
Device
Intervention Name(s)
Respiratory support with non-invasive ventilation (NIV)
Intervention Description
Patient with AECOPD is treated with NIV.
Primary Outcome Measure Information:
Title
Proportion with treatment failure of allocated respiratory support within 72 h after start of respiratory support.
Description
Treatment failure defined as intubation or switch to another method of non-invasive ventilation or death
Time Frame
start of treatment until 72 hours
Secondary Outcome Measure Information:
Title
intubation within 72 hours (component of primary outcome)
Description
independent of whether or not responsible primary endpoint
Time Frame
start of treatment until 72 hours
Title
proportion intubated within 7 calendar days after hospitalisation/randomization
Time Frame
start of treatment until 7 calender days after hospitalisation/randomization
Title
Overall survival at day 28 and day 90
Time Frame
start of treatment until day 90 after start of treatment
Title
(Invasive) ventilator-free days until day 28
Time Frame
start of treatment until day 28 after start of treatment
Title
(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
Title
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)
Title
Proportion requiring sedation
Time Frame
start of treatment until discharge or day 90 after start of treatment (whichever comes first)
Title
switch to another method of non-invasive ventilation within 72 hours (component of primary outcome)
Description
independent of whether or not responsible primary endpoint
Time Frame
start of treatment until 72 hours
Title
death within 72 hours (component of primary outcome)
Description
independent of whether or not responsible primary endpoint
Time Frame
start of treatment until 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: acute hypercapnic exacerbation of chronic obstructive pulmonary disease with pH < 7.35 pCO2 > 45mmHg age ≥ 18 years written informed consent Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hubert Wirtz
Phone
00493419712601
Email
hubert.wirtz@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Köppe-Bauernfeind
Phone
00493419716266
Email
nicole.koeppe-bauernfeind@zks.uni-leipzig.de
Facility Information:
Facility Name
München-Klinik Bogenhausen
City
München
State/Province
Bavaria
ZIP/Postal Code
81925
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Dodt, Prof.
Phone
0049 899270707549
Email
christoph.dodt@muenchen-klinik.de
Facility Name
Klinikum Emden
City
Emden
State/Province
Lower Saxony
ZIP/Postal Code
26721
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Bräunlich, PD Dr.
Phone
00494921981598
Email
j.braeunlich@klinikum-emden.de
Facility Name
Lungenklinik Hemer
City
Hemer
State/Province
North Rhine-Westphalia
ZIP/Postal Code
58675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Westhoff, Dr.
Phone
004923729082201
Email
michael.westhoff@lkhemer.de
Facility Name
University Hospital Leipzig
City
Leipzig
State/Province
Saxonia
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hubert Wirtz, Prof.
Phone
00493419712600
Email
hubert.wirtz@medizin.uni-leipzig.de
Facility Name
Sana Kliniken Ostholstein
City
Oldenburg In Holstein
State/Province
Schleswig-Holstein
ZIP/Postal Code
23758
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iris Koper, Dr.
Phone
00494361513140
Email
iris.koper@sana.de
Facility Name
Evangelische Lungenklinik
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Grohé, Prof.
Phone
004930 94802112
Email
christian.grohe@jsd.de

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
After publication of the major results
IPD Sharing 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.
Citations:
PubMed Identifier
35012620
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs