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

Not Applicable

Recruiting

• Conditions: COPD Exacerbation Acute
• Interventions: Device: Respiratory support with non-invasive ventilation (NIV); Device: Respiratory support with nasal high-flow (NHF)

• Registration Number: NCT04881409
• Lead Sponsor: University of Leipzig

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).

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-05-05
• Study Start: 2021-05-06
• Study First Posted: 2021-05-11
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-09
• Primary Completion: 2024-02-06
• Study Completion: 2024-10-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 720

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-invasive ventilation	Respiratory support with non-invasive ventilation (NIV)	Patient with AECOPD is treated with NIV
nasal high-flow	Respiratory support with nasal high-flow (NHF)	Patient with AECOPD is treated with NHF.

Primary Outcome Measures

Name	Time	Method
Proportion with treatment failure of allocated respiratory support within 72 h after start of respiratory support.	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

Secondary Outcome Measures

Name	Time	Method
switch to another method of non-invasive ventilation within 72 hours (component of primary outcome)	start of treatment until 72 hours	independent of whether or not responsible primary endpoint
intubation within 72 hours (component of primary outcome)	start of treatment until 72 hours	independent of whether or not responsible primary endpoint
death within 72 hours (component of primary outcome)	start of treatment until 72 hours	independent of whether or not responsible primary endpoint
Proportion requiring sedation	start of treatment until discharge or day 90 after start of treatment (whichever comes first)
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)

Trial Locations

Locations (6)

University Hospital Leipzig; 🇩🇪 Leipzig, Saxonia, Germany

Evangelische Lungenklinik; 🇩🇪 Berlin, Germany

Lungenklinik Hemer; 🇩🇪 Hemer, North Rhine-Westphalia, Germany

Sana Kliniken Ostholstein; 🇩🇪 Oldenburg In Holstein, Schleswig-Holstein, Germany

Klinikum Emden; 🇩🇪 Emden, Lower Saxony, Germany

München-Klinik Bogenhausen; 🇩🇪 München, Bavaria, Germany