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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04881409
Other study ID # ELVIS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 6, 2021
Est. completion date October 6, 2024

Study information

Verified date February 2022
Source University of Leipzig
Contact Hubert Wirtz
Phone 00493419712601
Email hubert.wirtz@medizin.uni-leipzig.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 720
Est. completion date October 6, 2024
Est. primary completion date February 6, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Respiratory support with nasal high-flow (NHF)
Patient with AECOPD is treated with NHF.
Respiratory support with non-invasive ventilation (NIV)
Patient with AECOPD is treated with NIV.

Locations

Country Name City State
Germany Evangelische Lungenklinik Berlin
Germany Klinikum Emden Emden Lower Saxony
Germany Lungenklinik Hemer Hemer North Rhine-Westphalia
Germany University Hospital Leipzig Leipzig Saxonia
Germany München-Klinik Bogenhausen München Bavaria
Germany Sana Kliniken Ostholstein Oldenburg In Holstein Schleswig-Holstein

Sponsors (1)

Lead Sponsor Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 intubation within 72 hours (component of primary outcome) independent of whether or not responsible primary endpoint start of treatment until 72 hours
Secondary proportion intubated within 7 calendar days after hospitalisation/randomization start of treatment until 7 calender days after hospitalisation/randomization
Secondary Overall survival at day 28 and day 90 start of treatment until day 90 after start of treatment
Secondary (Invasive) ventilator-free days until day 28 start of treatment until day 28 after start of treatment
Secondary (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
Secondary Intensive care unit (ICU) and hospital lengths of stay start of treatment until discharge or day 90 after start of treatment (whichever comes first)
Secondary Proportion requiring sedation start of treatment until discharge or day 90 after start of treatment (whichever comes first)
Secondary 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
Secondary death within 72 hours (component of primary outcome) independent of whether or not responsible primary endpoint start of treatment until 72 hours
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