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

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.

Study Overview

• Status: Recruiting
• Conditions: COPD Exacerbation Acute
• Intervention / Treatment: Device: Respiratory support with nasal high-flow (NHF); Device: Respiratory support with non-invasive ventilation (NIV)

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 Type: Interventional
• Enrollment (Anticipated): 720
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hubert Wirtz; Phone Number: 00493419712601; Email: hubert.wirtz@medizin.uni-leipzig.de
• Study Contact Backup: Name: Nicole Köppe-Bauernfeind; Phone Number: 00493419716266; Email: nicole.koeppe-bauernfeind@zks.uni-leipzig.de

Study Locations

• Germany
  • Berlin, Germany, 13125
    • Recruiting
    • Evangelische Lungenklinik
    • Contact: Christian Grohé, Prof.; Phone Number: 004930 94802112; Email: christian.grohe@jsd.de
  • Bavaria
    • München, Bavaria, Germany, 81925
      • Recruiting
      • München-Klinik Bogenhausen
      • Contact: Christoph Dodt, Prof.; Phone Number: 0049 899270707549; Email: christoph.dodt@muenchen-klinik.de
  • Lower Saxony
    • Emden, Lower Saxony, Germany, 26721
      • Recruiting
      • Klinikum Emden
      • Contact: Jens Bräunlich, PD Dr.; Phone Number: 00494921981598; Email: j.braeunlich@klinikum-emden.de
  • North Rhine-Westphalia
    • Hemer, North Rhine-Westphalia, Germany, 58675
      • Recruiting
      • Lungenklinik Hemer
      • Contact: Michael Westhoff, Dr.; Phone Number: 004923729082201; Email: michael.westhoff@lkhemer.de
  • Saxonia
    • Leipzig, Saxonia, Germany, 04103
      • Recruiting
      • University Hospital Leipzig
      • Contact: Hubert Wirtz, Prof.; Phone Number: 00493419712600; Email: hubert.wirtz@medizin.uni-leipzig.de
  • Schleswig-Holstein
    • Oldenburg In Holstein, Schleswig-Holstein, Germany, 23758
      • Recruiting
      • Sana Kliniken Ostholstein
      • Contact: Iris Koper, Dr.; Phone Number: 00494361513140; Email: iris.koper@sana.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nasal high-flow; Patient with AECOPD is treated with NHF.	Device: Respiratory support with nasal high-flow (NHF); Patient with AECOPD is treated with NHF.
Active Comparator: non-invasive ventilation; Patient with AECOPD is treated with NIV	Device: Respiratory support with non-invasive ventilation (NIV); Patient with AECOPD is treated with NIV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	start of treatment until 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intubation within 72 hours (component of primary outcome)	independent of whether or not responsible primary endpoint	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
Intensive care unit (ICU) and hospital lengths of stay		start of treatment until discharge or day 90 after start of treatment (whichever comes first)
Proportion requiring sedation		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	start of treatment until 72 hours
death within 72 hours (component of primary outcome)	independent of whether or not responsible primary endpoint	start of treatment until 72 hours

Collaborators and Investigators

• Sponsor: University of Leipzig

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Anticipated): February 6, 2024
• Study Completion (Anticipated): October 6, 2024

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: non-invasive ventilation; nasal high-flow
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ELVIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.

• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No