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DUET Versus Standard Interface for Hypercapnic COPD Patients

NCT05829083 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-09-10

No results posted yet for this study

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.

Conditions

  • COPD Exacerbation
  • Hypercapnia
  • COPD

Interventions

DEVICE

Asymmetric 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

DEVICE

Conventional nasal high flow cannula

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

Sponsors & Collaborators

  • Sotiria General Hospital

    collaborator OTHER

  • Larissa University Hospital

    lead OTHER

Principal Investigators

  • Konstantinos Gourgoulianis, Ph.D. · Larissa University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-18
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05829083 on ClinicalTrials.gov