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NCT Number: NCT07066566

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

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. 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. baseline characteristics will me monitored throughout the interventions 3. Esophageal pressure and minute ventilation will be monitored.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Larissa, Department of Pulmonary Medicine

Larissa, 41222, Greece

Location status: Recruiting

Location contact

Ioannis Dr Pantazopoulos, Associate Professor

CONTACT

[email protected]

+30 - 69445661525

Ioannis Dr Pantazopoulos, Associate Professor

PRINCIPAL_INVESTIGATOR

About this study

Each participant will undergo all phases of the study while seated comfortably, breathing room air. Vital signs, including blood pressure, heart rate, and peripheral oxygen saturation (%SpO₂), will be continuously monitored and recorded throughout.

Respiratory mechanics will be assessed using esophageal pressure (Pes) monitoring. A thin latex balloon catheter (10 cm long, 3-5 cm circumference; Cooper surgical, USA), filled with 0.5 mL of air, will be placed in the mid-esophagus (~45 cm from the nares) and will be connected to a pressure transducer (RSS-100HR, Hans Rudolph Inc., USA). Correct positioning will be confirmed by observing equal fluctuations in Pes and airway pressure (Paw) during occluded breaths. Balloon integrity will be verified before, after, and as needed during the procedure.

Participants will be instructed to breathe quietly on room air (FiO₂ 0.21) to allow for baseline assessment. Volume will be recorded using a heated pneumotachometer (Series 3813; Hans Rudolph Inc., USA) and the Research Pneumotach System (RSS100-HR), sampling at 50 Hz, a sampling rate exceeding the Nyquist criterion for respiratory signals. A bioelectrical impedance technology device (ExSpiron, Respiratory Motion Inc., Waltham, MA) will then be attached around the chest to assess lung volume changes.

Participants will then be randomized in a 1:1 ratio to one of two intervention sequences using a computer-generated randomization schedule.

  • Sequence 1: Symmetrical NHF Interface - 3-minute washout period - Asymmetrical NHF Interface
  • Sequence 2: Asymmetrical NHF Interface - 3-minute washout period - Symmetrical NHF Interface In the seated position, participants will both 15-minute phases, separated by a 3-minute washout period to prevent residual effects. During the "Symmetrical Interface" phase, participants will breathe using the conventional symmetrical NHF cannula, and during the asymmetrical phase, the asymmetrical interface (DUET, Fisher and Paykel Healthcare, Auckland, New Zealand) will be used. High-flow oxygen will be delivered using a commercial system (AIRVO 3; Fisher and Paykel Healthcare, Auckland, New Zealand) set at a flow of 50 L/min, temperature of 37°C, and FiO₂ of 0.21.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

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

Conventional nasal high flow cannula

Device

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

Primary outcomes

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ioannis Dr. Pantazopoulos, Associate Professor

CONTACT

[email protected]

+30- 6945661525

Sponsors and collaborators

Lead sponsor

Larissa University Hospital

Other

Registry information

Official study title

The Effect of Asymmetrical vs. Symmetrical High Flow Nasal Cannula on the Work of Breathing: A Randomised Cross-over Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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