The Effect of Asymmetrical vs. Symmetrical High Flow Nasal Cannula on the Work of Breathing

NCT07066566 | Recruiting

• 1 other identifier: 16171
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study randomized single-center crossover study is to evaluate the impact of asymmetrical versus symmetrical nasal high flow (NHF) therapy on work of breathing (WOB). The main question it aims to answer are: 1\. Does the asymmetrical NHF interface improve the work of breathing compared to the symmetrical NHF interface? Researchers will compare the symmetrical NHF interface to the symmetrical NHF interface to see if the the asymmetrical interface has a greater impact on the work of breathing. Participants will :

1. 1.receive NHF via both interfaces (FiO₂ 0.21, 50 L/min) for 15 minutes, in random order, with esophageal pressure monitoring and bioelectrical impedance analysis performed.
2. 2.baseline characteristics will me monitored throughout the interventions
3. 3.Esophageal pressure and minute ventilation will be monitored.

Conditions

Respiratory Disease (Clinically Stable Individuals - Patients Recovered From Respiratory Disease)

Outcome Measures

Primary Outcomes (2)

• Change in the pressure time product after the use of symmetrical high flow nasal interface for 15 minutes.

  This outcome measures the change in the Pressure-Time Product (PTP) before and after the application of a symmetrical high-flow nasal interface (HFNI) in patients requiring noninvasive respiratory support. The PTP is a physiological index that reflects the work of breathing and respiratory muscle effort. It is calculated using airway pressure and inspiratory time data over a defined period. The primary goal is to assess whether the symmetrical HFNI leads to a measurable reduction in the PTP, indicating improved respiratory mechanics and decreased patient effort.

  Baseline and 15 minutes

• Change in the pressure time product after the use of asymmetrical nasal high flow interface for 15 minutes.

  This outcome measures the change in the Pressure-Time Product (PTP) before and after the application of a symmetrical high-flow nasal interface (HFNI) in patients requiring noninvasive respiratory support. The PTP is a physiological index that reflects the work of breathing and respiratory muscle effort. It is calculated using airway pressure and inspiratory time data over a defined period. The primary goal is to assess whether the asymmetrical HFNI leads to a measurable reduction in the PTP, indicating improved respiratory mechanics and decreased patient effort.

  Baseline and 15 minutes

Study Arms (2)

Recovery patients from respiratory disease - Asymmetric or conventional nasal high flow cannula

EXPERIMENTAL

Patients recovered from acute respiratory disease will be randomized to NHF oxygen therapy with asymmetrical cannula or conventional cannula

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

Recovery patients from respiratory disease - Conventional or asymmetric nasal high flow cannula

ACTIVE COMPARATOR

Patients recovered from acute respiratory disease will be randomized to NHF oxygen therapy with conventional cannula or asymmetrical 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 patients' nostrils (size: one nostril of the patient should be fully occluded) Patients will be crossed - over between the 2 interventions

Recovery patients from respiratory disease - Asymmetric or conventional nasal high flow cannula; Recovery patients from respiratory disease - 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 cross - over between the 2 interventions

Recovery patients from respiratory disease - Asymmetric or conventional nasal high flow cannula; Recovery patients from respiratory disease - Conventional or asymmetric nasal high flow cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years old
• absence of symptoms and signs of respiratory failure (SpO2\>95% at FiΟ2 0.21)

You may not qualify if:

• pregnancy
• SpO2\<94% at FiΟ2 0.21
• neuromuscular disease
• contraindications to esophageal pressure monitoring (e.g., uncontrolled coagulopathy, esophageal disease, nasal trauma, allergy to local lidocaine)

Sponsors & Collaborators

• Larissa University Hospital: lead

Study Sites (1)

University Hospital of Larissa, Department of Pulmonary Medicine

Larissa, 41222, Greece

RECRUITING

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Demosthenes Makris

  Professor of Intensive Care Unit, University Hospital of Larissa

  STUDY CHAIR

Central Study Contacts

Ioannis Dr. Pantazopoulos, Associate Professor

CONTACT

+30- 6945661525; pantazopoulosioannis@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Respiratory & Emergency Medicine Faculty of Medicine, University of Thessaly, Greece

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 15, 2025
• Study Start: April 9, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)