RecruitingNot ApplicableNCT05829083

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


Sponsor

Larissa University Hospital

Enrollment

50 participants

Start Date

Jul 18, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two types of face masks used during non-invasive ventilation (breathing support through a mask, not a breathing tube) for people with COPD who are having a flare-up with dangerously high carbon dioxide levels. One mask is a standard mask; the other is a newer type called DUET. **You may be eligible if...** - You are having an acute flare-up of COPD - Your blood gas tests show that your carbon dioxide is too high (above 45 mmHg) and your blood pH is between 7.25 and 7.35 (mild to moderate acidosis) **You may NOT be eligible if...** - You have a severe facial deformity, facial burns, or a fixed blockage in your upper airway - You need an emergency breathing tube (e.g., you are unconscious, in respiratory arrest, or have uncontrolled agitation) - You have had a large amount of material inhaled into your lungs - You have a life-threatening heart rhythm problem - You are in severe shock that does not respond to fluids or medications - You have critically low oxygen levels in your blood Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAsymmetric nasal cannula - DUET

DUET asymmetric nasal high flow interface that fits best to the patients' nostrils (size: one nostril of the patient should be fully occluded) Patients will be crossed-over between the 2 interventions

DEVICEConventional nasal high flow cannula

Well-established conventional nasal high flow cannula (size: medium) Patients will be crossed-over between the 2 interventions


Locations(2)

Sotiria General Hospital

Athens, Greece

University Hospital of Larissa

Larissa, Greece

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NCT05829083


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