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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04004247
Recruitment Status : Enrolling by invitation
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
Military University Hospital, Prague
Information provided by (Responsible Party):
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?


Condition or disease Intervention/treatment Phase
Healthy Device: High Flow Nasal generator (AirVO2) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Approximately 12 volunteers
Masking: None (Open Label)
Primary Purpose: Other
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

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 Name: Full face mask connected to ventilator (Avea)




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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).

  5. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004247


Locations
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Czechia
Czech Technical University in Prague
Kladno, Czechia, 27201
Sponsors and Collaborators
Czech Technical University in Prague
Military University Hospital, Prague
Investigators
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Principal Investigator: Michal Sotak, MD., DESA Military University Hospital, Prague
Principal Investigator: Jan Filip Czech Technical University in Prague
Publications:
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Responsible Party: Czech Technical University in Prague
ClinicalTrials.gov Identifier: NCT04004247    
Other Study ID Numbers: HFNC-01
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Czech Technical University in Prague:
High Flow Oxygenation
Electrical Impedance Tomography
Non invasive ventilation
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes