HealthyHaFoNCT04004247
Effects of High Flow Nasal Cannula on Breathing and the Respiratory System Parameters
A study testing High Flow Nasal generator (AirVO2) in people with Healthy, run by Czech Technical University in Prague at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High Flow Nasal generator (AirVO2)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2019to 6 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers willing to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read the 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.
- Conditions
- Healthy
- Being tested
- High Flow Nasal generator (AirVO2)
- Keywords
- High Flow Oxygenation, Electrical Impedance Tomography, Non invasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal generator (AirVO2)Device
Also called Full face mask connected to ventilator (Avea)
High Flow Nasal Oxygenation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: High Flow Nasal generator (AirVO2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 1 hour
Calculation of Pressure Time Product (PTP) for estimation of Work of Breathing (WOB).
Compare PTP between conventional NIV and HFNO.
Measured: 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).
Measured: 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).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Jun 2019
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 12 volunteers
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Military University Hospital, Prague
- Responsible party
- Sponsor
- Investigators
- Michal Sotak, MD., DESA, Principal investigator, Military University Hospital, PragueJan Filip, Principal investigator, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004247
- Sponsor's protocol ID
- HFNC-01
- Acronym
- HaFo
- Status last verified
- Feb 2024
- First submitted
- 16 Jun 2019
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26329355
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Flow Nasal Cannula on Breathing and the Respiratory System Parameters
- ClinicalTrials.gov ID
- NCT04004247
- Acronym / sponsor ID
- HaFo / HFNC-01
- Conditions
- Healthy
- Keywords
- High Flow Oxygenation, Electrical Impedance Tomography, Non invasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Collaborators
- Military University Hospital, Prague
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 12 volunteers
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: High Flow Nasal generator (AirVO2)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers willing to participate
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flow Nasal generator (AirVO2)Also: Full face mask connected to ventilator (Avea)High Flow Nasal Oxygenation | Device | Experimental group |
Primary outcome
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).
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.
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Background: PubMed 26329355Parke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Sotak, MD., DESA principal investigator
Military University Hospital, Prague
Jan Filip principal investigator
Czech Technical University in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal generator (AirVO2) in people with Healthy, run by Czech Technical University in Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04004247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.