NCT04004247

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2024

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

4.7 years

First QC Date

June 16, 2019

Last Update Submit

February 6, 2024

Conditions

Healthy

Keywords

High Flow OxygenationElectrical Impedance TomographyNon invasive ventilation

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

Experimental group

EXPERIMENTAL

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)

Interventions

High Flow Nasal generator (AirVO2)DEVICE

High Flow Nasal Oxygenation

Also known as: Full face mask connected to ventilator (Avea)
Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers willing to participate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Czech Technical University in Prague

Kladno, 27201, Czechia

Location

Related Publications (1)

  • 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.

    PMID: 26329355BACKGROUND

Study Officials

  • Michal Sotak, MD., DESA

    Military University Hospital, Prague

    PRINCIPAL INVESTIGATOR

  • Jan Filip

    Czech Technical University in Prague

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 12 volunteers
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2019

First Posted

July 2, 2019

Study Start

June 1, 2019

Primary Completion

February 6, 2024

Study Completion

February 6, 2024

Last Updated

February 8, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)