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

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?

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: High Flow Nasal generator (AirVO2)

Detailed Description

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
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Kladno, Czechia, 27201
    • Czech Technical University in Prague

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 Names: Full face mask connected to ventilator (Avea)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of inspiratory pressure, pressure in a hypopharynx and pleural pressure estimation using oesophageal catheter on conventional non-invasive ventilation (NIV).	Using measurement of several pressures - inspiratory, oesophageal, nasopharyngeal (cm of H20 on conventional NIV.	1 hour
Measurement of inspiratory pressure, pressure in a hypopharynx and pleural pressure estimation using oesophageal catheter on High flow nasal oxygenation (HFNO).	Using measurement of several pressures - inspiratory, oesophageal, nasopharyngeal (cm of H20) on High flow nasal oxygenation (HFNO).	1 hour
Calculation of Pressure Time Product (PTP) for estimation of Work of Breathing (WOB).	Compare PTP between conventional NIV and HFNO.	up to 8 weeks
Monitoring of EIT during spontaneous ventilation on conventional non-invasive ventilation (NIV).	EIT for description of distribution of ventilation on conventional NIV at different levels of PEEP (cm H20).	1 hour
Monitoring of EIT during spontaneous ventilation with High flow nasal oxygenation (HFNO).	EIT for description of distribution of ventilation with HFNO with different flow rate levels (litres per minute).	1 hour

Collaborators and Investigators

• Sponsor: Czech Technical University in Prague
• Collaborators: Military University Hospital, Prague
• Investigators: Principal Investigator: Michal Sotak, MD., DESA, Military University Hospital, Prague; Principal Investigator: Jan Filip, Czech Technical University in Prague

Publications and helpful links

General Publications

• Parke RL, Bloch A, McGuinness SP. Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers. Respir Care. 2015 Oct;60(10):1397-403. doi: 10.4187/respcare.04028. Epub 2015 Sep 1.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): February 6, 2024
• Study Completion (Actual): February 6, 2024

Study Registration Dates

• First Submitted: June 16, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Non invasive ventilation; Electrical Impedance Tomography; High Flow Oxygenation
• Other Study ID Numbers: HFNC-01

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