DUET Versus Standard Interface for Hypercapnic COPD Patients

NCT05829083 | Recruiting DMC

• 1 other identifier: 51886
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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:

1. 1.A greater decrease in the patients' carbon dioxide
2. 2.A greater decrease in respiratory rate and less dyspnea
3. 3.Less need for advanced oxygen therapy measures
4. 4.Same tolerance and comfort
5. 5.Lower heart rate and blood pressure

Conditions

COPD Exacerbation; Hypercapnia; COPD

Outcome Measures

Primary Outcomes (1)

• Arterial PCO2

  Change in PCO2

  Immediately before and after the application of 3 hours of nasal high flow therapy (3 hours for each cannula type)

Secondary Outcomes (9)

• Respiratory rate

  Immediately before and after the application of 3 hours of nasal high flow therapy (3 hours for each cannula type)

• Invasive or non-invasive mechanical ventilation

  At the end of hospitalization (assessed up to 6 months), researchers will note if the patient needed invasive or non-invasive mechanical ventilation

• Tolerance

  Immediately before and after the application of 3 hours of nasal high flow therapy (3 hours for each cannula type)

• Comfort

  Immediately before and after the application of 3 hours of nasal high flow therapy (3 hours for each cannula type)

• Heart rate

  Immediately before and after the application of 3 hours of nasal high flow therapy (3 hours for each cannula type)

Study Arms (2)

Hypercapnic COPD patient - Asymmetric or conventional nasal high flow cannula

EXPERIMENTAL

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

Device: Asymmetric nasal cannula - DUET; Device: Conventional nasal high flow cannula

Hypercapnic COPD patient - Conventional or asymmetric nasal high flow cannula

ACTIVE COMPARATOR

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

Device: Asymmetric nasal cannula - DUET; Device: Conventional nasal high flow cannula

Interventions

Asymmetric nasal cannula - DUET DEVICE

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

Hypercapnic COPD patient - Asymmetric or conventional nasal high flow cannula; Hypercapnic COPD patient - Conventional or asymmetric nasal high flow cannula

Conventional nasal high flow cannula DEVICE

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

Hypercapnic COPD patient - Asymmetric or conventional nasal high flow cannula; Hypercapnic COPD patient - Conventional or asymmetric nasal high flow cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• massive aspiration
• persistent inability to remove respiratory secretions
• severe haemodynamic instability unresponsive to fluids and vasoactive drugs
• severe ventricular or supraventricular arrhythmias
• life threatening hypoxaemia

Sponsors & Collaborators

• Larissa University Hospital: lead
• Sotiria General Hospital: collaborator

Study Sites (2)

Sotiria General Hospital

Athens, 11527, Greece

RECRUITING

University Hospital of Larissa

Larissa, 41110, Greece

RECRUITING

Related Publications (4)

• Ischaki E, Pantazopoulos I, Zakynthinos S. Nasal high flow therapy: a novel treatment rather than a more expensive oxygen device. Eur Respir Rev. 2017 Aug 9;26(145):170028. doi: 10.1183/16000617.0028-2017. Print 2017 Sep 30.

  PMID: 28794144 BACKGROUND

• Pantazopoulos I, Daniil Z, Moylan M, Gourgoulianis K, Chalkias A, Zakynthinos S, Ischaki E. Nasal High Flow Use in COPD Patients with Hypercapnic Respiratory Failure: Treatment Algorithm & Review of the Literature. COPD. 2020 Feb;17(1):101-111. doi: 10.1080/15412555.2020.1715361. Epub 2020 Jan 22.

  PMID: 31965868 BACKGROUND

• Papalampidou A, Bibaki E, Boutlas S, Pantazopoulos I, Athanasiou N, Moylan M, Vlachakos V, Grigoropoulos V, Eleftheriou K, Daniil Z, Gourgoulianis K, Kalomenidis I, Zakynthinos S, Ischaki E. Nasal high-flow oxygen versus noninvasive ventilation in acute exacerbation of COPD: protocol for a randomised noninferiority clinical trial. ERJ Open Res. 2020 Oct 19;6(4):00114-2020. doi: 10.1183/23120541.00114-2020. eCollection 2020 Oct.

  PMID: 33123554 BACKGROUND

• Crimi C, Noto A, Madotto F, Ippolito M, Nolasco S, Campisi R, De Vuono S, Fiorentino G, Pantazopoulos I, Chalkias A, Libra A, Mattei A, Scala R, Clini EM, Ergan B, Lujan M, Winck JC, Giarratano A, Carlucci A, Gregoretti C, Groff P, Cortegiani A; COVID-HIGH Investigators. High-flow nasal oxygen versus conventional oxygen therapy in patients with COVID-19 pneumonia and mild hypoxaemia: a randomised controlled trial. Thorax. 2023 Apr;78(4):354-361. doi: 10.1136/thoraxjnl-2022-218806. Epub 2022 May 17.

  PMID: 35580898 BACKGROUND

MeSH Terms

Conditions

Hypercapnia; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Konstantinos Gourgoulianis, Ph.D.

  Larissa University Hospital

  STUDY CHAIR

Central Study Contacts

Ioannis Pantazopoulos, Ph.D.

CONTACT

6945661525; pantazopoulosioannis@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 25, 2023
• Study Start: July 18, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Within 1 year of study completion
• Access Criteria: Reasonable request

Locations

GR (2)