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Clinical Trials/NCT04004247
NCT04004247
Completed
Not Applicable

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

Czech Technical University in Prague1 site in 1 country12 target enrollmentJune 1, 2019
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Czech Technical University in Prague
Enrollment
12
Locations
1
Primary Endpoint
Measurement of inspiratory pressure, pressure in a hypopharynx and pleural pressure estimation using oesophageal catheter on conventional non-invasive ventilation (NIV).
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
February 6, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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).

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).

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).

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.

Study Sites (1)

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