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NHF vs NIV in Patients With Acute Exacerbation of COPD

NCT03466385 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 498

Last updated 2020-02-20

No results posted yet for this study

Summary

Although non-invasive ventilation (NIV) usage has increased significantly over time in COPD exacerbation, a great percentage of patients (\~30%) present contraindications to NIV or cannot tolerate it. Nasal high flow (NHF) has been introduced for the management of hypoxemic respiratory failure in adults with favorable effects on ventilation and respiratory mechanics. The above mentioned NHF positive effects has been observed also in stable COPD patients with or without chronic hypercapnia.

In this study, the investigators hypothesize that NHF is not inferior to NIV for respiratory support in patients with COPD exacerbation and acute or acute on chronic hypercapnic respiratory failure.

Conditions

Interventions

DEVICE

Nasal High Flow

Patients admitted to emergency department with COPD exacerbation combined with mild to moderate acute or acute on chronic hypercapnic respiratory failure will be randomized in one of the two study groups. In case of NHF it will be commence immediately with pre-defined settings

DEVICE

Non-Invasive Ventilation

Patients admitted to emergency department with COPD exacerbation combined with mild to moderate acute or acute on chronic hypercapnic respiratory failure will be randomized in one of the two study groups. In case of NIV it will be commence immediately with pre-defined settings

Sponsors & Collaborators

  • Venizeleio General Hospital, Heraklion, Crete

    collaborator UNKNOWN

  • Larissa University Hospital

    collaborator OTHER

  • Sotiria General Hospital

    collaborator OTHER

  • Evangelismos Hospital

    lead OTHER

Principal Investigators

  • Spyros Zakynthinos, MD, PhD, FCCP · Evangelismos Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-15
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03466385 on ClinicalTrials.gov