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

Not Applicable
Completed
Conditions
Healthy
Interventions
Device: High Flow Nasal generator (AirVO2)
Registration Number
NCT04004247
Lead Sponsor
Czech Technical University in Prague
Brief Summary

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?

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Experimental groupHigh Flow Nasal generator (AirVO2)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.
Primary Outcome Measures
NameTimeMethod
Measurement of inspiratory pressure, pressure in a hypopharynx and pleural pressure estimation using oesophageal catheter on conventional non-invasive ventilation (NIV).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).1 hour

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

Monitoring of EIT during spontaneous ventilation with High flow nasal oxygenation (HFNO).1 hour

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

Monitoring of EIT during spontaneous ventilation on conventional non-invasive ventilation (NIV).1 hour

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

Calculation of Pressure Time Product (PTP) for estimation of Work of Breathing (WOB).up to 8 weeks

Compare PTP between conventional NIV and HFNO.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Czech Technical University in Prague

🇨🇿

Kladno, Czechia

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