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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLarissa University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age ≥18 years old

absence of symptoms and signs of respiratory failure (SpO2>95% at FiΟ2 0.21)

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Recovery patients from respiratory disease - Asymmetric or conventional nasal high flow cannulaExperimental treatment 2 interventions
Group B: Recovery patients from respiratory disease - Conventional or asymmetric nasal high flow cannulaActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 15 minutes
2

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.

Time frame
Baseline and 15 minutes

Secondary outcomes

Other outcomes

Sponsors and contacts

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