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

July 15, 2025 updated by: Ioannis Pantazopoulos, Larissa University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Greece
      • Larissa, Greece, 41222
        • Recruiting
        • University Hospital of Larissa, Department of Pulmonary Medicine
        • Contact:
        • Principal Investigator:
          • Ioannis Dr Pantazopoulos, Associate Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Recovery patients from respiratory disease - Asymmetric or conventional nasal high flow cannula
Patients recovered from acute respiratory disease will be randomized to NHF oxygen therapy with asymmetrical cannula or conventional cannula
Device: Asymmetric nasal cannula - DUET
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
Device: Conventional nasal high flow cannula
Well - established conventional nasal high flow cannula (size: medium) Patients will be cross - over between the 2 interventions
Active Comparator: Recovery patients from respiratory disease - Conventional or asymmetric nasal high flow cannula
Patients recovered from acute respiratory disease will be randomized to NHF oxygen therapy with conventional cannula or asymmetrical cannula
Device: Asymmetric nasal cannula - DUET
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
Device: Conventional nasal high flow cannula
Well - established conventional nasal high flow cannula (size: medium) Patients will be cross - over between the 2 interventions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 15 minutes
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.
Baseline and 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Larissa University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Demosthenes Makris, Professor of Intensive Care Unit, University Hospital of Larissa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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