HypoxemiaOPTIMARFNCT05838326
'Optiflow + Duet' Interface' vs 'Standard' High Flow Nasal Cannula
A study testing Symmetrical high flow nasal cannula (HFNO) and Asymmetrical high flow nasal cannula (DUET HFNO) in people with Hypoxemia, run by University of Padova at 1 site in Italy.
Trial summary
High-flow nasal cannula (HFNC) therapy is increasingly used in the management of acute respiratory failure. Its clinical application has been largely investigated in chronic obstructive pulmonary disease (COPD) patients but only marginally in patients experiencing acute respiratory failure after extubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Symmetrical high flow nasal cannula (HFNO) and Asymmetrical high flow nasal cannula (DUET HFNO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 8 May 2023to 30 Jul 2023
- 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
- age >18 years old;
- invasive mechanical ventilation > 24h;
- acute respiratory failure within 120 minutes after extubation (defined during a spontaneous trial using Venturi mask and assessing a PaO2/FiO2 ratio < 300;
- absence of Sars-Cov-2 positivity;
- absence of cardiological or long-term respiratory disease
Who cannot join
- pregnancy
- tracheostomy
- non-invasive ventilation after extubation
- second tracheal intubation
- contraindications for EIT belt
- facial or nose abnormalities
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Anaesthesia and Intensive Care, Padua University hospital
Padova, 35120
About this study
Official title: Physiological Effects of High Flow Oxygen Therapy Using 'Optiflow + Duet' Interface vs 'Standard' High Flow Nasal Cannula for Acute Respiratory Failure After Extubation. The OPTIMARF Study.
High-flow nasal cannula (HFNC) therapy is increasingly used in the management of acute respiratory failure. Its clinical application has been largely investigated in chronic obstructive pulmonary disease (COPD) patients but only marginally in patients experiencing acute respiratory failure after extubation. Promising data have been published in vitro about new asymmetrical high flow nasal cannula, named 'Optiflow + DUET'. Positive airway pressure, that dynamically changes with breathing, and clearance of anatomical dead space are the key mechanisms of noninvasive respiratory support with nasal high flow. Pressure mainly depends on flow rate and nare occlusion. The hypothesis is that an increase in asymmetrical occlusion of the nares leads to an improvement in dead-space clearance resulting in a reduction in re-breathing and breathing work.
Read the detailed description
A prospective cross-over RCT on the effects of 'Optiflow + DUET' as compared to convetional symmetrical high flow cannula and Venturi mask.
- Conditions
- Hypoxemia
- Being tested
- Symmetrical high flow nasal cannula (HFNO), Asymmetrical high flow nasal cannula (DUET HFNO)
- Keywords
- asymmetrical nasal cannula, hypoxemia, DUET
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symmetrical high flow nasal cannula (HFNO)Device
After a 'baseline' trial using Venturi Mask, within the first 120 minutes after extubation, and assessing a PaO2/FiO2 ratio < 300, patients will be randomly assigned to a first 1h-phase of 'conventional HFNO' or 'DUET HFNO'. At the end of each session several clinical parameters (i.e. DUS, EIT, ABGs, comfort, VAS) will be collected.
Specifically, Gas-flow rate will be set at a maximum of 60 L/min, temperature at a maximum of 37°C, while FiO2 will be adjusted to maintain SpO2 between 92 and 98%.
Asymmetrical high flow nasal cannula (DUET HFNO)Device
After a 'baseline' trial using Venturi Mask, within the first 120 minutes after extubation, and assessing a PaO2/FiO2 ratio < 300, patients will be randomly assigned to a first 1h-phase of 'DUET HFNO' vs 'conventional HFNO'. At the end of each session several clinical parameters (i.e. DUS, EIT, ABGs, comfort, VAS) will be collected.
Specifically, Gas-flow rate will be set at a maximum of 60 L/min, temperature at a maximum of 37°C, while FiO2 will be adjusted to maintain SpO2 between 92 and 98%.
A 5-10min 'washout' phase using VM, between different interfaces, will be allowed.
| Study group | Role | What they receive |
|---|---|---|
| Symmetrical high flow nasal cannula (HFNO) | Active comparator | After a 'baseline' trial using Venturi Mask, within the first 120 minutes after extubation, and assessing a arterial oxygen pressure (PaO2) and inspiratory oxygen fraction (FiO2) ratio < 300, patients will be randomly assigned to a first 1h-phase of 'conventional HFNO' or 'DUET HFNO'. At the end of each session several clinical parameters (i.e. DUS, EIT, ABGs, comfort, VAS) will be collected.
Specifically, Gas-flow rate will be set at a maximum of 60 L/min, temperature at a maximum of 37°C, while FiO2 will be adjusted to maintain a peripheral saturation (SpO2) between 92 and 98%. Receives: Device: Symmetrical high flow nasal cannula (HFNO) |
| Asymmetrical high flow nasal cannula (DUET HFNO) | Active comparator | After a 'baseline' trial using Venturi Mask, within the first 120 minutes after extubation, and assessing a PaO2/FiO2 ratio < 300 (as described above), patients will be randomly assigned to a second 1h-phase of 'DUET HFNO' vs 'conventional HFNO'. At the end of each session several clinical parameters (i.e. DUS, EIT, ABGs, comfort, VAS) will be collected.
Specifically, Gas-flow rate will be set at a maximum of 60L/min, temperature at a maximum of 37°C, while FiO2 will be adjusted to maintain SpO2 between 92 and 98%. Receives: Device: Asymmetrical high flow nasal cannula (DUET HFNO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathing effort
To evaluate changes, between arms, in breathing effort (as assessed by diaphragm ultrasound (DUS)).
Measured: Last 10 minutes of 1 hour-trial
Lung aeration
To evaluate changes, between arms, in lung aeration (as assessed by the end-expiratory lung impedance (delta EELI) through EIT.
Measured: Last 10 minutes of 1 hour-trial
Secondary outcomes (6)
Minute ventilation (MV) (L/min)
To evaluate breathing pattern
Measured: Last 10 minutes of 1 hour-trial
corrected MV (L/min)
To evaluate breathing pattern
Measured: Last 10 minutes of 1 hour-trial
Breathing heterogeneity
To evaluate changes, between arms, in ventilation distribution (as assessed by pendelluft (yes/not), respiratory rates/min, tidal volume (ml), global inhomogeneity index through EIT)
Measured: Last 10 minutes of 1 hour-trial
Comfort
To evaluate changes in comfort, between arms, as assessed by NRS scale
Measured: Last 10 minutes of 1h-trial
Dyspnea
To evaluate changes in dyspnea, between arms, as assessed by VAS scale
Measured: Last 10 minutes of 1h-trial
Gas exchange
To evaluate changes, between arms, in gas exchange (as assessed by PaO2 mmHg, pCO2 mmHg, pH through ABGs)
Measured: Last 10 minutes of 1h-trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start8 May 2023
- Primary completion30 Jun 2023
- Study completion30 Jul 2023
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 HypoxemiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annalisa Boscolo, MD, Principal investigator, AOUP, DIMED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838326
- Sponsor's protocol ID
- AOP2949
- Acronym
- OPTIMARF
- Status last verified
- Dec 2023
- First submitted
- 5 Apr 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boscolo A, Pettenuzzo T, Zarantonello F, Sella N, Pistollato E, De Cassai A, Congedi S, Paiusco I, Bertoldo G, Crociani S, Toma F, Mormando G, Lorenzoni G, Gregori D, Navalesi P. Asymmetrical high-flow nasal cannula performs similarly to standard interface in patients with acute hypoxemic post-extubation respiratory failure: a pilot study. BMC Pulm Med. 2024 Jan 8;24(1):21. doi: 10.1186/s12890-023-02820-x.
PubMed 38191347
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of High Flow Oxygen Therapy Using 'Optiflow + Duet' Interface vs 'Standard' High Flow Nasal Cannula for Acute Respiratory Failure After Extubation. The OPTIMARF Study.
- ClinicalTrials.gov ID
- NCT05838326
- Acronym / sponsor ID
- OPTIMARF / AOP2949
- Conditions
- Hypoxemia
- Keywords
- asymmetrical nasal cannula, hypoxemia, DUET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 1 May 2023 (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) therapy is increasingly used in the management of acute respiratory failure. Its clinical application has been largely investigated in chronic obstructive pulmonary disease (COPD) patients but only marginally in patients experiencing acute respiratory failure after extubation. Promising data have been published in vitro about new asymmetrical high flow nasal cannula, named 'Optiflow + DUET'. Positive airway pressure, that dynamically changes with breathing, and clearance of anatomical dead space are the key mechanisms of noninvasive respiratory support with nasal high flow. Pressure mainly depends on flow rate and nare occlusion. The hypothesis is that an increase in asymmetrical occlusion of the nares leads to an improvement in dead-space clearance resulting in a reduction in re-breathing and breathing work.
Detailed description
A prospective cross-over RCT on the effects of 'Optiflow + DUET' as compared to convetional symmetrical high flow cannula and Venturi mask.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symmetrical high flow nasal cannula (HFNO) | Active comparator | Device: Symmetrical high flow nasal cannula (HFNO)After a 'baseline' trial using Venturi Mask, within the first 120 minutes after extubation, and assessing a arterial oxygen pressure (PaO2) and inspiratory oxygen fraction (FiO2) ratio < 300, patients will be randomly assigned to a first 1h-phase of 'conventional HFNO' or 'DUET HFNO'. At the end of each session several clinical parameters (i.e. DUS, EIT, ABGs, comfort, VAS) will be collected. Specifically, Gas-flow rate will be set at a maximum of 60 L/min, temperature at a maximum of 37°C, while FiO2 will be adjusted to maintain a peripheral saturation (SpO2) between 92 and 98%. |
| Asymmetrical high flow nasal cannula (DUET HFNO) | Active comparator | Device: Asymmetrical high flow nasal cannula (DUET HFNO)After a 'baseline' trial using Venturi Mask, within the first 120 minutes after extubation, and assessing a PaO2/FiO2 ratio < 300 (as described above), patients will be randomly assigned to a second 1h-phase of 'DUET HFNO' vs 'conventional HFNO'. At the end of each session several clinical parameters (i.e. DUS, EIT, ABGs, comfort, VAS) will be collected. Specifically, Gas-flow rate will be set at a maximum of 60L/min, temperature at a maximum of 37°C, while FiO2 will be adjusted to maintain SpO2 between 92 and 98%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age >18 years old;
- invasive mechanical ventilation > 24h;
- acute respiratory failure within 120 minutes after extubation (defined during a spontaneous trial using Venturi mask and assessing a PaO2/FiO2 ratio < 300;
- absence of Sars-Cov-2 positivity;
- absence of cardiological or long-term respiratory disease
Key exclusion criteria (6 listed)
- pregnancy
- tracheostomy
- non-invasive ventilation after extubation
- second tracheal intubation
- contraindications for EIT belt
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 |
|---|---|---|
| Symmetrical high flow nasal cannula (HFNO)After a 'baseline' trial using Venturi Mask, within the first 120 minutes after extubation, and assessing a PaO2/FiO2 ratio < 300, patients will be randomly assigned to a first 1h-phase of 'conventional HFNO' or 'DUET HFNO'. At the end of each session several clinical parameters (i.e. DUS, EIT, ABGs, comfort, VAS) will be collected. Specifically, Gas-flow rate will be set at a maximum of 60 L/min, temperature at a maximum of 37°C, while FiO2 will be adjusted to maintain SpO2 between 92 and 98%. | Device | Symmetrical high flow nasal cannula (HFNO) |
| Asymmetrical high flow nasal cannula (DUET HFNO)After a 'baseline' trial using Venturi Mask, within the first 120 minutes after extubation, and assessing a PaO2/FiO2 ratio < 300, patients will be randomly assigned to a first 1h-phase of 'DUET HFNO' vs 'conventional HFNO'. At the end of each session several clinical parameters (i.e. DUS, EIT, ABGs, comfort, VAS) will be collected. Specifically, Gas-flow rate will be set at a maximum of 60 L/min, temperature at a maximum of 37°C, while FiO2 will be adjusted to maintain SpO2 between 92 and 98%. A 5-10min 'washout' phase using VM, between different interfaces, will be allowed. | Device | Asymmetrical high flow nasal cannula (DUET HFNO) |
Primary outcome
Breathing effort
Time frame: Last 10 minutes of 1 hour-trial
To evaluate changes, between arms, in breathing effort (as assessed by diaphragm ultrasound (DUS)).
Lung aeration
Time frame: Last 10 minutes of 1 hour-trial
To evaluate changes, between arms, in lung aeration (as assessed by the end-expiratory lung impedance (delta EELI) through EIT.
6 secondary outcomes
Minute ventilation (MV) (L/min)
Time frame: Last 10 minutes of 1 hour-trial
corrected MV (L/min)
Time frame: Last 10 minutes of 1 hour-trial
Breathing heterogeneity
Time frame: Last 10 minutes of 1 hour-trial
Comfort
Time frame: Last 10 minutes of 1h-trial
Dyspnea
Time frame: Last 10 minutes of 1h-trial
Gas exchange
Time frame: Last 10 minutes of 1h-trial
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 27 Dec 2023.
- Derived from this study: PubMed 38191347Boscolo A, Pettenuzzo T, Zarantonello F, Sella N, Pistollato E, De Cassai A, Congedi S, Paiusco I, Bertoldo G, Crociani S, Toma F, Mormando G, Lorenzoni G, Gregori D, Navalesi P. Asymmetrical high-flow nasal cannula performs similarly to standard interface in patients with acute hypoxemic post-extubation respiratory failure: a pilot study. BMC Pulm Med. 2024 Jan 8;24(1):21. doi: 10.1186/s12890-023-02820-x.
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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.
Annalisa Boscolo, MD principal investigator
AOUP, DIMED
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symmetrical high flow nasal cannula (HFNO) and Asymmetrical high flow nasal cannula (DUET HFNO) in people with Hypoxemia, run by University of Padova at 1 site in Italy.
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 5 inclusion and 6 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 27 Dec 2023. 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 Italy. 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?
Breathing effort (time frame: Last 10 minutes of 1 hour-trial). The study lists 2 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 NCT05838326, 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 27 Dec 2023.