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

NCT ID: NCT04004247

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2024-02-06

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

12 volunteers
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

High Flow Nasal generator (AirVO2)

Intervention Type DEVICE

High Flow Nasal Oxygenation

Interventions

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High Flow Nasal generator (AirVO2)

High Flow Nasal Oxygenation

Intervention Type DEVICE

Other Intervention Names

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Full face mask connected to ventilator (Avea)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Military University Hospital, Prague

OTHER

Sponsor Role collaborator

Czech Technical University in Prague

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michal Sotak, MD., DESA

Role: PRINCIPAL_INVESTIGATOR

Military University Hospital, Prague

Jan Filip

Role: PRINCIPAL_INVESTIGATOR

Czech Technical University in Prague

Locations

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Czech Technical University in Prague

Kladno, , Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type BACKGROUND
PMID: 26329355 (View on PubMed)

Other Identifiers

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HFNC-01

Identifier Type: -

Identifier Source: org_study_id

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