NCT05829083 DUET Versus Standard Interface for Hypercapnic COPD Patients
| NCT ID | NCT05829083 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Larissa University Hospital |
| Condition | COPD Exacerbation |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-07-18 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-07-18 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Konstantinos Gourgoulianis, Ph.D.
STUDY CHAIR
Larissa University Hospital
Frequently Asked Questions
Who can join the NCT05829083 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying COPD Exacerbation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05829083 currently recruiting?
Yes, NCT05829083 is actively recruiting participants. Contact the research team at pantazopoulosioannis@yahoo.com for enrollment information.
Where is the NCT05829083 trial being conducted?
This trial is being conducted at Athens, Greece, Larissa, Greece.
Who is sponsoring the NCT05829083 clinical trial?
NCT05829083 is sponsored by Larissa University Hospital. The principal investigator is Konstantinos Gourgoulianis, Ph.D. at Larissa University Hospital. The trial plans to enroll 50 participants.
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