Nasal High Flow Use in COPD Patients with Hypercapnic Respiratory Failure: Treatment Algorithm & Review of the Literature.
Ioannis Pantazopoulos, Zoi Daniil, Melanie Moylan...
https://pubmed.ncbi.nlm.nih.gov/31965868/Actively Recruiting
Led by Larissa University Hospital · Updated on 2025-09-10
50
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are evaluating two types of nasal high flow oxygen devices in adults with chronic obstructive pulmonary disease COPD who are experiencing a mild to moderate worsening of their breathing symptoms with high carbon dioxide levels. The study aims to compare the new asymmetric nasal high flow interface called DUET with the standard conventional nasal high flow cannula. Key questions include whether the asymmetric interface better reduces carbon dioxide levels, lowers breathing rate and discomfort, decreases the need for advanced oxygen therapies, and maintains similar comfort and vital signs compared to the conventional device. In this randomized crossover trial, 50 patients with COPD exacerbation and mild to moderate hypercapnic respiratory failure will receive both treatments in sequence. Half will start with the DUET asymmetric nasal cannula for 3 hours followed by the conventional cannula for 3 hours after a 30-minute break, while the other half will receive the devices in the reverse order. Both devices deliver heated oxygen at 60 liters per minute and 37C, adjusted to keep oxygen saturation between 88% and 92%. Patients will be monitored closely in a semi-reclined position using the same equipment model. Participants will undergo several assessments including blood tests to measure carbon dioxide levels, respiratory rate, heart rate, blood pressure, breathing comfort, and dyspnea scores before and after each treatment period. Continuous monitoring with pulse oximetry, carbon dioxide sensors, and respiratory motion sensors will track breathing patterns. Researchers will also evaluate tolerance by measuring noise, dryness, and overall comfort. The goal is to determine which device better supports breathing while maintaining patient comfort. The trial is conducted under strict clinical regulations with safety measures allowing switch to more advanced ventilation if needed.
CONDITIONS
DUET Versus Standard Interface for Hypercapnic COPD Patients
I
Ioannis Pantazopoulos, Ph.D.
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Larissa University Hospital
Lead Sponsor
Sotiria General Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 7 hours
Participants receive two types of nasal high flow oxygen therapy in random order, each lasting 3 hours, separated by a 30-minute washout period of conventional oxygen therapy. The study compares the DUET asymmetric nasal cannula and the conventional nasal high flow cannula to assess respiratory and comfort outcomes.
1 baseline visit with continuous monitoring during the 7-hour treatment and crossover period
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/33123554/Larissa University Hospital
Lead Sponsor
Sotiria General Hospital
Collaborating Sponsor