Trials / Unknown
UnknownNCT04881409
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 720 (estimated)
- Sponsor
- University of Leipzig · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Respiratory support with nasal high-flow (NHF) | Patient with AECOPD is treated with NHF. |
| DEVICE | Respiratory support with non-invasive ventilation (NIV) | Patient with AECOPD is treated with NIV. |
Timeline
- Start date
- 2021-05-06
- Primary completion
- 2024-02-06
- Completion
- 2024-10-06
- First posted
- 2021-05-11
- Last updated
- 2022-02-09
Locations
6 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT04881409. Inclusion in this directory is not an endorsement.