DUET Versus Standard Interface for Hypercapnic COPD Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLarissa University Hospital
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Asymmetric nasal cannula - DUET
- Conventional nasal high flow cannula
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Larissa University Hospital
Lead sponsor
Sotiria General Hospital
Collaborator
Source ClinicalTrials.gov