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

COPD Exacerbation Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04881409
• Other study ID #: ELVIS
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• COPD Exacerbation Acute
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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