DUET Versus Standard Interface for Hypercapnic COPD Patients (NCT05829083) | Clinical Trial Compass
RecruitingNot Applicable
DUET Versus Standard Interface for Hypercapnic COPD Patients
Greece50 participantsStarted 2023-07-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Arterial PCO2
Timeframe: Immediately before and after the application of 3 hours of nasal high flow therapy (3 hours for each cannula type)