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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Greece
Sotiria General Hospital
RECRUITING
Athens
University Hospital of Larissa
RECRUITING
Larissa
Contact Information
Primary
Ioannis Pantazopoulos, Ph.D.
pantazopoulosioannis@yahoo.com
6945661525
Time Frame
Start Date: 2023-07-18
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 50
Treatments
Experimental: Hypercapnic COPD patient - Asymmetric or conventional nasal high flow cannula
Patients with acute exacerbation of COPD and mild to moderate hypercapnic respiratory failure will be randomized to NHF oxygen therapy with asymmetric cannula OR conventional cannula
Active_comparator: Hypercapnic COPD patient - Conventional or asymmetric nasal high flow cannula
Patients with acute exacerbation of COPD and mild to moderate hypercapnic respiratory failure will be randomized to NHF oxygen therapy with conventional cannula or Asymmetric cannula
Sponsors
Leads: Larissa University Hospital
Collaborators: Sotiria General Hospital

This content was sourced from clinicaltrials.gov