Effects of High Flow Nasal Cannula on Breathing and the Respiratory System Parameters (HaFo)
|ClinicalTrials.gov Identifier: NCT04004247|
Recruitment Status : Enrolling by invitation
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
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?
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Device: High Flow Nasal generator (AirVO2)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Approximately 12 volunteers|
|Masking:||None (Open Label)|
|Official Title:||Effects of High Flow Nasal Cannula on Breathing and the Respiratory System Parameters|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Experimental group
10-12 young healthy volunteers. Placed on semi-sitting position on the bed (40 deg.elevation). Calibration of electrical impedance tomography (EIT) on defined tidal volume 500ml, done with 500ml syringe connected to closed breathing circuit using full face mask as an interface.
Insertion an esophageal and nasopharyngeal catheter for pressures measurement. In the first phase - spontaneous breathing with full face mask at 0, 5 and 10 cm H20 levels of PEEP.
In the second phase - high flow oxygenation through nasal cannula, start with flow rate 10 L/min with gradual increase up to 60 L/min.
Spirometry to determine functional residual capacity (FRC) before and after procedure is planed.
Device: High Flow Nasal generator (AirVO2)
High Flow Nasal Oxygenation
Other Name: Full face mask connected to ventilator (Avea)
- 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.
- 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).
- 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.
- 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).
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004247
|Czech Technical University in Prague|
|Kladno, Czechia, 27201|
|Principal Investigator:||Michal Sotak, MD., DESA||Military University Hospital, Prague|
|Principal Investigator:||Jan Filip||Czech Technical University in Prague|