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Completed

NCT Number: NCT04004247

Effects of High Flow Nasal Cannula on Breathing and the Respiratory System Parameters

The aim of this study is a detailed investigation of the effect of High Flow Nasal Oxygenation (HFNO) on respiratory system characteristics and ventilation parameters in healthy adult subjects and the subsequent use of measured data to answer the following questions:

What level of positive end expiratory pressure (PEEP) causes a HFNO with different flow rates? Does HFNO work as pressure support or does it act more like a Continuous Positive Airway Pressure (CPAP) ventilation?

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Czech Technical University in Prague

Kladno, 27201, Czechia

About this study

High Flow Oxygen through nasal cannula is widely used in the setting of hypoxemic respiratory failure of heterogenous etiology with very good patients compliance.

However, the evidence of what level of PEEP or pressure support (if any) with different flow rates is weak.

Our goal is to determine these effects and compare them with standard approach with non-invasive ventilation via full face mask.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy volunteers willing to participate

Exclusion criteria

  • general contraindications for oesophageal catheter insertion: oesophageal varices, bleeding disorders (including anticoagulant medication), diverticulitis, oesophageal tumors, history of recent oesophageal/gastric surgery, recent epistaxis,
  • sinusitis
  • allergy to local anesthetics
  • subject refusal

Treatment and study plan

High Flow Nasal generator (AirVO2)

Device

High Flow Nasal Oxygenation

Other names: Full face mask connected to ventilator (Avea)

Primary outcomes

  1. Measurement of inspiratory pressure, pressure in a hypopharynx and pleural pressure estimation using oesophageal catheter on conventional non-invasive ventilation (NIV).

    Time frame: 1 hour

    Using measurement of several pressures - inspiratory, oesophageal, nasopharyngeal (cm of H20 on conventional NIV.

  2. Measurement of inspiratory pressure, pressure in a hypopharynx and pleural pressure estimation using oesophageal catheter on High flow nasal oxygenation (HFNO).

    Time frame: 1 hour

    Using measurement of several pressures - inspiratory, oesophageal, nasopharyngeal (cm of H20) on High flow nasal oxygenation (HFNO).

  3. Calculation of Pressure Time Product (PTP) for estimation of Work of Breathing (WOB).

    Time frame: up to 8 weeks

    Compare PTP between conventional NIV and HFNO.

  4. Monitoring of EIT during spontaneous ventilation on conventional non-invasive ventilation (NIV).

    Time frame: 1 hour

    EIT for description of distribution of ventilation on conventional NIV at different levels of PEEP (cm H20).

  5. Monitoring of EIT during spontaneous ventilation with High flow nasal oxygenation (HFNO).

    Time frame: 1 hour

    EIT for description of distribution of ventilation with HFNO with different flow rate levels (litres per minute).

Sponsors and collaborators

Lead sponsor

Czech Technical University in Prague

Other

Collaborators

  • Military University Hospital, Prague

Registry information

Acronym: HaFo

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jul 2, 2019
Registry last updated
Feb 8, 2024

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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