Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05829083

DUET Versus Standard Interface for Hypercapnic COPD Patients

Led by Larissa University Hospital · Updated on 2025-09-10

50

Participants Needed

2

Research Sites

123 weeks

Total Duration

On this page

Sponsors

L

Larissa University Hospital

Lead Sponsor

S

Sotiria General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to compare the new asymmetric nasal high flow interface with the conventional high flow nasal cannula in patients with COPD exacerbation. The main questions the study aims to answer are: • Does the use of the asymmetric interface lead to: 1. A greater decrease in the patients' carbon dioxide 2. A greater decrease in respiratory rate and less dyspnea 3. Less need for advanced oxygen therapy measures 4. Same tolerance and comfort 5. Lower heart rate and blood pressure Participants will be asked to: Wear the asymmetric and conventional cannulas for 3 hours each with a 30 minute gap in-between. Arterial blood samples and various clinical parameters will be collected throughout the study period. Researchers will compare the effect of asymmetric versus conventional cannulas to answer the aforementioned questions.

CONDITIONS

Official Title

DUET Versus Standard Interface for Hypercapnic COPD Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acute exacerbation of COPD causing worsening respiratory symptoms and medication change
  • Mild to moderate acute hypercapnic respiratory failure with pH between 7.25 and 7.35 and arterial CO2 tension above 45 mmHg
Not Eligible

You will not qualify if you...

  • Acute on chronic hypercapnic respiratory failure
  • Severe facial deformity, facial burns, or fixed upper airway obstruction
  • Conditions requiring imminent intubation or invasive ventilation such as respiratory or cardiac arrest
  • Diminished consciousness (Glasgow coma score below 8)
  • Psychomotor agitation not controlled by sedation
  • Massive aspiration
  • Inability to clear respiratory secretions
  • Severe hemodynamic instability unresponsive to fluids and drugs
  • Severe ventricular or supraventricular arrhythmias
  • Life-threatening low blood oxygen levels

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Sotiria General Hospital

Athens, Greece, 11527

Actively Recruiting

2

University Hospital of Larissa

Larissa, Greece, 41110

Actively Recruiting

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Research Team

I

Ioannis Pantazopoulos, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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