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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Asymmetric nasal cannula - DUET
DeviceDUET 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
Conventional nasal high flow cannula
DeviceWell-established conventional nasal high flow cannula (size: medium) Patients will be crossed-over between the 2 interventions
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Hypercapnic COPD patient - Asymmetric or conventional nasal high flow cannulaExperimental treatment 2 interventions
Group B: Hypercapnic COPD patient - Conventional or asymmetric nasal high flow cannulaActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Arterial PCO2
Change in PCO2
Time frame
Immediately before and after the application of 3 hours of nasal high flow therapy (3 hours for each cannula type)Secondary outcomes
1
Respiratory rate
Change in respiratory rate
Time frame
Immediately before and after the application of 3 hours of nasal high flow therapy (3 hours for each cannula type)2
Invasive or non-invasive mechanical ventilation
Need for Invasive or non-invasive mechanical ventilation
Time frame
At the end of hospitalization (assessed up to 6 months), researchers will note if the patient needed invasive or non-invasive mechanical ventilation3
Tolerance
Subjective tolerance of patients using visual analog scale (Score range: 0-10, higher scores indicate higher levels of tolerance)
Time frame
Immediately before and after the application of 3 hours of nasal high flow therapy (3 hours for each cannula type)4
Comfort
Subjective comfort of patients using visual analog scale (Score range: 0-10, higher scores indicate higher levels of comfort)
Time frame
Immediately before and after the application of 3 hours of nasal high flow therapy (3 hours for each cannula type)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Larissa University Hospital
Lead sponsor
Sotiria General Hospital
Collaborator
Source ClinicalTrials.gov