NCT05829083Recruiting
DUET Versus Standard Interface for Hypercapnic COPD Patients
Asymmetric (DUET) Versus Conventional Nasal High Flow Interface for Management of Hypercapnic Patients With Mild to Moderate Acute Exacerbation of COPD: A Randomized, Crossover Clinical Trial
Source: ClinicalTrials.gov · Last updated 10 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 9 Mar 2023
- Start date
- 18 Jul 2023
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Larissa University Hospital
- Diseases
- COPD
- NCT number
- NCT05829083
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 18 Jul 2023 to the primary completion date, 1 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- severe haemodynamic instability unresponsive to fluids and vasoactive drugs
Other illness
- acute on chronic hypercapnic respiratory failure
- indication for imminent intubation and invasive mechanical ventilation (i.e. respiratory or cardiac arrest, diminished consciousness (Glasgow coma score \<8)
- severe ventricular or supraventricular arrhythmias
Other
- severe facial deformity, facial burns, fixed upper airway obstruction
- psychomotor agitation inadequately controlled by sedation
- massive aspiration
- persistent inability to remove respiratory secretions
- life threatening hypoxaemia
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sotiria General Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.