DUET Versus Standard Interface for Hypercapnic COPD Patients

Recruiting now · Not applicable

Conditions studied: COPD Exacerbation, Hypercapnia, COPD

In brief

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.

Key facts

Study ID

NCT05829083

Run by

Larissa University Hospital

People needed

50

Starts

2023-07-18

Expected to finish

2025-12-01

Last updated by the study team

2025-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Sotiria General Hospital — Athens, Greece (enrolling)
• University Hospital of Larissa — Larissa, Greece (enrolling)

Full record on ClinicalTrials.gov

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