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Search / Trial NCT05829083

DUET Versus Standard Interface for Hypercapnic COPD Patients

Launched by LARISSA UNIVERSITY HOSPITAL · Apr 24, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new type of breathing device called the asymmetric nasal high flow interface to see if it works better than the standard high flow nasal cannula for patients with chronic obstructive pulmonary disease (COPD) who are experiencing an exacerbation, which is a worsening of their symptoms. The researchers want to find out if the new device can help lower carbon dioxide levels in the blood, reduce how fast patients are breathing, make them feel less short of breath, and decrease the need for more intense oxygen treatments, all while being just as comfortable as the standard device.

To participate in the trial, individuals should be between the ages of 65 and 74 and be experiencing an acute exacerbation of COPD with mild to moderate respiratory failure. Participants will wear both breathing devices for three hours each, with a short break in between, while researchers monitor their blood and various health measurements. This study is currently recruiting participants, and it’s important to know that certain conditions, like severe facial deformities or needing immediate life support, would make someone ineligible to join.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • acute exacerbation of COPD (defined as any worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to change in medication)
  • mild-to-moderate acute hypercapnic respiratory failure (defined as 7.35\>pH\>7.25 and arterial CO2 tension (PaCO2) \>45 mmHg)
  • Exclusion Criteria:
  • acute on chronic hypercapnic respiratory failure
  • severe facial deformity, facial burns, fixed upper airway obstruction
  • indication for imminent intubation and invasive mechanical ventilation (i.e. respiratory or cardiac arrest, diminished consciousness (Glasgow coma score \<8)
  • psychomotor agitation inadequately controlled by sedation
  • massive aspiration
  • persistent inability to remove respiratory secretions
  • severe haemodynamic instability unresponsive to fluids and vasoactive drugs
  • severe ventricular or supraventricular arrhythmias
  • life threatening hypoxaemia

About Larissa University Hospital

Larissa University Hospital is a leading academic medical institution dedicated to advancing healthcare through innovative clinical research and education. As a prominent sponsor of clinical trials, the hospital integrates cutting-edge scientific inquiry with patient-centered care, fostering a collaborative environment for researchers, healthcare professionals, and participants. With a commitment to improving medical outcomes, Larissa University Hospital emphasizes ethical practices, rigorous methodologies, and interdisciplinary approaches in its clinical trials, contributing significantly to the development of new therapies and interventions across various medical fields.

Locations

Larissa, , Greece

Athens, , Greece

Patients applied

0 patients applied

Trial Officials

Konstantinos Gourgoulianis, Ph.D.

Study Chair

Larissa University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported