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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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COPD Exacerbation Acute

Intervention / Treatment
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* Device: Respiratory support with nasal high-flow (NHF)
* Device: Respiratory support with non-invasive ventilation (NIV)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomization to NHF or NIV
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal high-flow, non-invasive ventilation