Clinical trial NCT04004247: Effects of High Flow Nasal Cannula on Breathing and the Respiratory System Parameters
Official title: Effects of High Flow Nasal Cannula on Breathing and the Respiratory System Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: High Flow Oxygenation
Electrical Impedance Tomography
Non invasive ventilation
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
Collaborators: name: Military University Hospital, Prague
First posted: 2019-07-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 12 volunteers
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of inspiratory pressure, pressure in a hypopharynx and pleural pressure estimation using oesophageal catheter on conventional non-invasive ventilation (NIV).
timeFrame: 1 hour
measure: Measurement of inspiratory pressure, pressure in a hypopharynx and pleural pressure estimation using oesophageal catheter on High flow nasal oxygenation (HFNO).
timeFrame: 1 hour
measure: Calculation of Pressure Time Product (PTP) for estimation of Work of Breathing (WOB).
timeFrame: up to 8 weeks
measure: Monitoring of EIT during spontaneous ventilation on conventional non-invasive ventilation (NIV).
timeFrame: 1 hour
measure: Monitoring of EIT during spontaneous ventilation with High flow nasal oxygenation (HFNO).
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: Czech Technical University in Prague
Study officials:
affiliation: Military University Hospital, Prague
name: Michal Sotak, MD., DESA
role: PRINCIPAL_INVESTIGATOR
affiliation: Czech Technical University in Prague
name: Jan Filip
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.