Oxygen DeficiencyHFNCNCT06398951
HFNC vs Two Nare HFNC in Extubated Patients
A study testing Two nare high flow nasal cannula in people with Oxygen Deficiency, run by Peninsula Health at 1 site in Australia.
Trial summary
High flow nasal cannula (HFNC) are introduced to clinical practice to improve oxygenation. Our group were the first to report the use of HFNC in extubated patients that showed comparable delivery of oxygen and improved comfort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Deficiency
- What is being tested?
- Two nare high flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jul 2023to 1 Sep 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All intubated patients imminently requiring extubation with family consent for admittance into the trial that meet the follow criteria:
- P/F ratio between > 150 prior to extubation
- Has a functional arterial catheter to allow sample of arterial blood gasses.
Who cannot join
- Patients being extubated due to withdrawal of therapy Patients being extubated, that are expected to imminently die post extubation P/F Ratio :< 150 Patients extubated on to non-invasive ventilation Patients with known epistaxis or nasal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Conventional High Flow Nasal Cannula vs Two-nare Size High Flow Nasal Cannula: A Randomized Crossover Trial in Extubated Patients
High flow nasal cannula (HFNC) are introduced to clinical practice to improve oxygenation. Our group were the first to report the use of HFNC in extubated patients that showed comparable delivery of oxygen and improved comfort. These HFNC are subsequently shown to be useful in several clinical conditions in critically ill patients including respiratory failure due to hypoxia, hypercapnia (exacerbation of chronic obstructive lung disease), or post-extubation, pre-intubation oxygenation, and others.
Recently a new mode of high flow oxygen therapy has been presented on the market where the prongs of high flow have two different diameters. These two-nare size high flow nasal cannula are capable of delivering gases at a flow rate of 15-50 L/min, similar to the conventional HFNP but the difference in the diameters provide different levels of positive pressure as compared to conventional HFNP. This positive pressure could help in gas exchange of patients who need more oxygen. These devices are approved by the Therapeutic Goods Administration (TGA); the medicine and therapeutic regulatory agency of the Australian Government.
Our aim is to compare the two size nare high flow nasal cannula with conventional high flow nasal cannula in extubated patients in intensive care unit in a randomised crossover trial. The comparison will include arterial blood gasses, physiological data including heart rate, respiratory rate, saturations as well as comfort and tolerance of the patients to two size nare high flow nasal cannuale.
Read the detailed description
This is a randomised crossover study of ventilated patients suitable for extubation was conducted. Potential patients were clinically assessed for suitability of extubation and arterial blood gasses (ABG) were performed prior to extubation to ensure the patients had optimal gas exchange. If found to be suitable for extubation, patients were extubated and were provided with a high flow blend of oxygen and air by a high flow face mask at a rate of 40 litres per minute delivering an FiO2 to ensure an oxygen saturation of 93% + 1 for 30 minutes. At the end of this 30 minute stabilization, ABG were performed and heart rate, blood pressure, and Glasgow coma score (GCS) were recorded. If the patients remained stable they were randomized to either protocol A (Duet HFNP for 30 minutes followed by conventional HFNP for 30 minutes) or protocol B ( conventional HFNP for 30 minutes followed by Duet HFNP for 30 minutes). During both protocols gas flow rate and FiO2 were maintained at exactly the same settings as used during the stabilization period. Blood gases and other physiological observations (heart rate, blood pressure, and respiratory rate, saturations, GCS, comfort score and tolerance score) were recorded at the end of each protocol. The bed side nurse assessed comfort and tolerance of patients to both the devices by a 5-point Likert scale as shown below. For the purpose of this study only medium size cannulas were used to maintain consistency. Subgroup Comparisions will be performed between those with and without nasogastric tubes and between male and female patients. Randomization is performed using sequentially numbered, sealed, opaque envelope to maintain allocation concealment.
Determine patient's comfort:
Patients provided the comfort for both duet HFNP and conventional HFNP prongs using a 5-point Likert scale;
- No discomfort,
- Little bit discomfort,
- Little more discomfort,
- Whole lot more discomfort
- Worst discomfort.
Determine patient's tolerance:
The bedside nurse documented the patient's tolerance using a 5-point Likert scale.
0 Patient never removes the apparatus and does not complain
- Patient complains about keeping apparatus on
- Patient request removal of the apparatus
- Removal of the apparatus by the patient once
- Removal of multiple times or non-compliance.
- Conditions
- Oxygen Deficiency
- Being tested
- Two nare high flow nasal cannula
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two nare high flow nasal cannulaDevice
Recently a new mode of high flow oxygen therapy has presented on the market where the prongs of high flow have different diameters .These two-nare size high flow nasal cannula are capable of delivering gases at a flow rate of 15-50 L/min, similar to the conventional HFNP but the difference in the diameters provide different levels of positive pressure as compared to conventional HFNP.
| Study group | Role | What they receive |
|---|---|---|
| Two Nare (Duet) high flow nasal cannula | Active comparator | Recently a new mode of high flow oxygen therapy has presented on the market where the cannula of high flow have different diameters. Left cannula larger in diameter than the right. These two-nare size high flow nasal cannula are capable of delivering gases at a flow rate of 15-60 L/min, similar to the conventional HFNP but the difference in the diameters provide different levels of positive pressure as compared to conventional HFNP. The two nare nasal cannula will be used for 30 minutes to assess the gas exchange, hemodynamic parameters, the tolerance and comfort of the device to the patient. Receives: Device: Two nare high flow nasal cannula |
| Conventional High flow nasal cannula | Placebo comparator | Conventional high flow nasal cannula that has been used for many years will be compared with two-nare high flow nasal cannula. The two nare nasal cannula will be used for 30 minutes to assess the gas exchange, hemodynamic parameters, the tolerance and comfort of the device to the patient. Receives: Device: Two nare high flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood gasses (PaO2 in mmHg)
To compare if there is difference in PaO2 between two nare and connventional high flow nasal cannula.
Measured: 30 minutes each for a total of one hour.
Blood gasses (PaCO2 in mmHg)
To compare if there is difference in PaCO2 between two nare and connventional high flow nasal cannula.
Measured: 30 minutes each for a total of one hour.
Blood gasses (SaO2 percentage)
To compare if there is difference in SaO2 between two nare and connventional high flow nasal cannula.
Measured: 30 minutes each for a total of one hour.
Secondary outcomes (4)
blood pressure (mmHg)
To compare if there is difference in blood pressure between two nare and connventional high flow nasal cannula.
Measured: 30 minutes each for a total of one hour.
Respiratory rate (breaths per minute)
To compare if there is difference in respiratory rate between two nare and connventional high flow nasal cannula.
Measured: 30 minutes each for a total of one hour.
Tolerance as assessed by a 5-point Likert scale ranging from 0-4.
To compare if there is difference in tolerance assessed by bedside nurse between two nare and connventional high flow nasal cannula.
Measured: 30 minutes each for a total of one hour.
Comfort as assessed by a 5-point Likert scale ranging from 1-5.
To compare if there is difference in comfort as reported by the patient between two nare and connventional high flow nasal cannula.
Measured: 30 minutes each for a total of one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Jul 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
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 Oxygen DeficiencyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peninsula Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- RAVINDRANATH TIRUVOIPATI, PhD, Principal investigator, Peninsula Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398951
- Sponsor's protocol ID
- 87400
- Acronym
- HFNC
- Status last verified
- Feb 2024
- First submitted
- 24 Mar 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tiruvoipati R, Reddy MP, Paul E, Gupta S, Subramaniam A, Zhang D, Haji K. A comparison of conventional high-flow nasal cannula vs the duet high-flow nasal cannula in extubated patients: a randomized crossover trial. Eur J Med Res. 2025 Mar 26;30(1):205. doi: 10.1186/s40001-025-02447-0.
PubMed 40140950
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Conventional High Flow Nasal Cannula vs Two-nare Size High Flow Nasal Cannula: A Randomized Crossover Trial in Extubated Patients
- ClinicalTrials.gov ID
- NCT06398951
- Acronym / sponsor ID
- HFNC / 87400
- Conditions
- Oxygen Deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Peninsula HealthOther government
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 3 May 2024 (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.
High flow nasal cannula (HFNC) are introduced to clinical practice to improve oxygenation. Our group were the first to report the use of HFNC in extubated patients that showed comparable delivery of oxygen and improved comfort. These HFNC are subsequently shown to be useful in several clinical conditions in critically ill patients including respiratory failure due to hypoxia, hypercapnia (exacerbation of chronic obstructive lung disease), or post-extubation, pre-intubation oxygenation, and others.
Recently a new mode of high flow oxygen therapy has been presented on the market where the prongs of high flow have two different diameters. These two-nare size high flow nasal cannula are capable of delivering gases at a flow rate of 15-50 L/min, similar to the conventional HFNP but the difference in the diameters provide different levels of positive pressure as compared to conventional HFNP. This positive pressure could help in gas exchange of patients who need more oxygen. These devices are approved by the Therapeutic Goods Administration (TGA); the medicine and therapeutic regulatory agency of the Australian Government.
Our aim is to compare the two size nare high flow nasal cannula with conventional high flow nasal cannula in extubated patients in intensive care unit in a randomised crossover trial. The comparison will include arterial blood gasses, physiological data including heart rate, respiratory rate, saturations as well as comfort and tolerance of the patients to two size nare high flow nasal cannuale.
Detailed description
This is a randomised crossover study of ventilated patients suitable for extubation was conducted. Potential patients were clinically assessed for suitability of extubation and arterial blood gasses (ABG) were performed prior to extubation to ensure the patients had optimal gas exchange. If found to be suitable for extubation, patients were extubated and were provided with a high flow blend of oxygen and air by a high flow face mask at a rate of 40 litres per minute delivering an FiO2 to ensure an oxygen saturation of 93% + 1 for 30 minutes. At the end of this 30 minute stabilization, ABG were performed and heart rate, blood pressure, and Glasgow coma score (GCS) were recorded. If the patients remained stable they were randomized to either protocol A (Duet HFNP for 30 minutes followed by conventional HFNP for 30 minutes) or protocol B ( conventional HFNP for 30 minutes followed by Duet HFNP for 30 minutes). During both protocols gas flow rate and FiO2 were maintained at exactly the same settings as used during the stabilization period. Blood gases and other physiological observations (heart rate, blood pressure, and respiratory rate, saturations, GCS, comfort score and tolerance score) were recorded at the end of each protocol. The bed side nurse assessed comfort and tolerance of patients to both the devices by a 5-point Likert scale as shown below. For the purpose of this study only medium size cannulas were used to maintain consistency. Subgroup Comparisions will be performed between those with and without nasogastric tubes and between male and female patients. Randomization is performed using sequentially numbered, sealed, opaque envelope to maintain allocation concealment.
Determine patient's comfort:
Patients provided the comfort for both duet HFNP and conventional HFNP prongs using a 5-point Likert scale;
- No discomfort,
- Little bit discomfort,
- Little more discomfort,
- Whole lot more discomfort
- Worst discomfort.
Determine patient's tolerance:
The bedside nurse documented the patient's tolerance using a 5-point Likert scale.
0 Patient never removes the apparatus and does not complain
- Patient complains about keeping apparatus on
- Patient request removal of the apparatus
- Removal of the apparatus by the patient once
- Removal of multiple times or non-compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two Nare (Duet) high flow nasal cannula | Active comparator | Device: Two nare high flow nasal cannulaRecently a new mode of high flow oxygen therapy has presented on the market where the cannula of high flow have different diameters. Left cannula larger in diameter than the right. These two-nare size high flow nasal cannula are capable of delivering gases at a flow rate of 15-60 L/min, similar to the conventional HFNP but the difference in the diameters provide different levels of positive pressure as compared to conventional HFNP. The two nare nasal cannula will be used for 30 minutes to assess the gas exchange, hemodynamic parameters, the tolerance and comfort of the device to the patient. |
| Conventional High flow nasal cannula | Placebo comparator | Device: Two nare high flow nasal cannulaConventional high flow nasal cannula that has been used for many years will be compared with two-nare high flow nasal cannula. The two nare nasal cannula will be used for 30 minutes to assess the gas exchange, hemodynamic parameters, the tolerance and comfort of the device to the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All intubated patients imminently requiring extubation with family consent for admittance into the trial that meet the follow criteria:
- P/F ratio between > 150 prior to extubation
- Has a functional arterial catheter to allow sample of arterial blood gasses.
Key exclusion criteria (1 listed)
- Patients being extubated due to withdrawal of therapy Patients being extubated, that are expected to imminently die post extubation P/F Ratio :< 150 Patients extubated on to non-invasive ventilation Patients with known epistaxis or nasal surgery.
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 |
|---|---|---|
| Two nare high flow nasal cannulaRecently a new mode of high flow oxygen therapy has presented on the market where the prongs of high flow have different diameters .These two-nare size high flow nasal cannula are capable of delivering gases at a flow rate of 15-50 L/min, similar to the conventional HFNP but the difference in the diameters provide different levels of positive pressure as compared to conventional HFNP. | Device | Conventional High flow nasal cannula, Two Nare (Duet) high flow nasal cannula |
Primary outcome
Blood gasses (PaO2 in mmHg)
Time frame: 30 minutes each for a total of one hour.
To compare if there is difference in PaO2 between two nare and connventional high flow nasal cannula.
Blood gasses (PaCO2 in mmHg)
Time frame: 30 minutes each for a total of one hour.
To compare if there is difference in PaCO2 between two nare and connventional high flow nasal cannula.
Blood gasses (SaO2 percentage)
Time frame: 30 minutes each for a total of one hour.
To compare if there is difference in SaO2 between two nare and connventional high flow nasal cannula.
4 secondary outcomes
blood pressure (mmHg)
Time frame: 30 minutes each for a total of one hour.
Respiratory rate (breaths per minute)
Time frame: 30 minutes each for a total of one hour.
Tolerance as assessed by a 5-point Likert scale ranging from 0-4.
Time frame: 30 minutes each for a total of one hour.
Comfort as assessed by a 5-point Likert scale ranging from 1-5.
Time frame: 30 minutes each for a total of one hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 40140950Tiruvoipati R, Reddy MP, Paul E, Gupta S, Subramaniam A, Zhang D, Haji K. A comparison of conventional high-flow nasal cannula vs the duet high-flow nasal cannula in extubated patients: a randomized crossover trial. Eur J Med Res. 2025 Mar 26;30(1):205. doi: 10.1186/s40001-025-02447-0.
- Individual participant dataSharing planned: Undecided
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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.
RAVINDRANATH TIRUVOIPATI, PhD principal investigator
Peninsula Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two nare high flow nasal cannula in people with Oxygen Deficiency, run by Peninsula Health at 1 site in Australia.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 May 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 Australia. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Blood gasses (PaO2 in mmHg) (time frame: 30 minutes each for a total of one hour.). The study lists 3 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 NCT06398951, 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 3 May 2024.