Comparing new nasal interface with standard cannula for 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
NA · Larissa University Hospital · NCT05829083
This study is testing a new type of nasal breathing device against a standard one to see which helps people with COPD feel better during a flare-up.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Larissa University Hospital (other) |
| Locations | 2 sites (Athens and 1 other locations) |
| Trial ID | NCT05829083 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of a new asymmetric nasal high flow interface against a conventional high flow nasal cannula in patients experiencing acute exacerbation of COPD. Participants will wear each type of cannula for three hours, with a 30-minute break in between, while various clinical parameters and arterial blood samples are collected. The study will assess differences in carbon dioxide levels, respiratory rate, dyspnea, and the need for advanced oxygen therapy. The research is conducted at two hospitals in Greece, following a randomized crossover design.
Who should consider this trial
Good fit: Ideal candidates are patients presenting with acute exacerbation of COPD and mild-to-moderate acute hypercapnic respiratory failure.
Not a fit: Patients with severe facial deformities, imminent intubation needs, or severe hemodynamic instability are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of COPD exacerbations, reducing carbon dioxide levels and enhancing patient comfort.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving respiratory outcomes in COPD patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Athens and 1 other locations
- Sotiria General Hospital — Athens, Greece (RECRUITING)
- University Hospital of Larissa — Larissa, Greece (RECRUITING)
Study contacts
- Study coordinator: Ioannis Pantazopoulos, Ph.D.
- Email: pantazopoulosioannis@yahoo.com
- Phone: 6945661525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: COPD Exacerbation, Hypercapnia, COPD