Respiratory Failure with HypoxiaHVNINCT06746636
Comparison Between Four Weaning Methods from High-velocity Nasal Insufflation Device in Acute Hypoxemic Respiratory Failure
A study testing High velocity nasal insufflation in people with Respiratory Failure with Hypoxia, run by Assiut University.
Trial summary
High-flow nasal oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters/ min of heated and fully humidified gas with a fraction of inspired oxygen (FIO2) ranging between 21% and 100% . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Failure with Hypoxia
- What is being tested?
- High velocity nasal insufflation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This study will include Patients over 18 years receiving respiratory support through HVNI for acute hypoxemic respiratory failure
- Those eligible for weaning according to European Respiratory Society weaning criteria
Who cannot join
- Extensive facial trauma or burn II. Refusal to participate. III. Usual long-term treatment with NIV for chronic disease IV. Tracheotomy or other upper airway disorders
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
High-flow nasal oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters/ min of heated and fully humidified gas with a fraction of inspired oxygen (FIO2) ranging between 21% and 100% . High-flow nasal oxygen therapy has become an increasingly popular choice of therapy due to the potential complications of invasive ventilation and the frequent uncomfortable or life-threatening adverse effects that are produced in non-invasive ventilation (NIV) . The HFNO allows the modification of only two variables: the percentage of oxygen being delivered and the rate of gas flow . Numerous well-designed studies have been conducted into the use of the HFNC in the treatment of critically ill patients, and HFNC is now widely used in the treatment of patients with various diagnoses including acute hypoxemic respiratory failure or acute respiratory distress syndrome (ARDS) , and is used in post-extubation treatment, post-cardiothoracic surgery respiratory distress , and respiratory compromise induced by heart failure .
High-velocity nasal insufflation (HVNI) is a form of HFNC that utilizes a small bore nasal cannula to generate higher velocities of gas delivery than its counterparts using large bore HFNC. HVNI can accomplish a complete purge of extrathoracic dead space and may be able to provide ventilatory support in patients with acute hypercapnic respiratory failure in addition to oxygenation support.
This study is necessary because, even though studies were being conducted to determine both the optimal technique for HFNO delivery and the clinical setting in which it is most useful, the best strategy for weaning from HVNI remains unknown. It has also not been established at what point a patient should be considered stable enough to attempt for withdrawing the HVNI
Read the detailed description
High-flow nasal oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters/ min of heated and fully humidified gas with a fraction of inspired oxygen (FIO2) ranging between 21% and 100% . High-flow nasal oxygen therapy has become an increasingly popular choice of therapy due to the potential complications of invasive ventilation and the frequent uncomfortable or life-threatening adverse effects that are produced in non-invasive ventilation (NIV) . The HFNO allows the modification of only two variables: the percentage of oxygen being delivered and the rate of gas flow . Numerous well-designed studies have been conducted into the use of the HFNC in the treatment of critically ill patients, and HFNC is now widely used in the treatment of patients with various diagnoses including acute hypoxemic respiratory failure or acute respiratory distress syndrome (ARDS) , and is used in post-extubation treatment , post-cardiothoracic surgery respiratory distress , and respiratory compromise induced by heart failure.
High-velocity nasal insufflation (HVNI) is a form of HFNC that utilizes a small bore nasal cannula to generate higher velocities of gas delivery than its counterparts using large bore HFNC. HVNI can accomplish a complete purge of extrathoracic dead space and may be able to provide ventilatory support in patients with acute hypercapnic respiratory failure in addition to oxygenation support .
This study is necessary because, even though studies were being conducted to determine both the optimal technique for HFNO delivery and the clinical setting in which it is most useful, the best strategy for weaning from HVNI remains unknown. It has also not been established at what point a patient should be considered stable enough to attempt to start withdrawing the HVNI
- Conditions
- Respiratory Failure with Hypoxia
- Being tested
- High velocity nasal insufflation
- Keywords
- HVNI, HFNC, HFNO, weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High velocity nasal insufflationDevice
- HVNI was supplied using a Vapotherm Precision Flow [Precision Flow Plus, Vapotherm, INC. U.S.A. device].
| Study group | Role | What they receive |
|---|---|---|
| Flow reduction | Experimental | the flow will gradually be reduced by 10 L/ min/h. When it reaches 20 L/min, FiO2 reduction will then begin at 0.1 /h until it reaches 0.3. Receives: Device: High velocity nasal insufflation |
| Oxygen reduction | Experimental | FiO2 will gradually be reduced by 0.1 /h until it reaches 0.3. At this point, the flow will be reduced by 10 L/min/h until it reaches 20 L/min. Receives: Device: High velocity nasal insufflation |
| Sudden reduction | Experimental | HVNI will be abruptly discontinued after fulfilling weaning criteria provided that flow and Fio2 are less than 40 L\min and 40% Receives: Device: High velocity nasal insufflation |
| Flow and oxygen reduction | Experimental | both flow and FiO2 will be gradually reduced simultaneously at a rate of 10 L/min and 0.1 /h, respectively, until they reach 20 L/min for flow and 0.3 for FiO2 Receives: Device: High velocity nasal insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total weaning period (from the first time of being ready to wean till 48h after liberation of HVNI)
period taken for liberation from HVNI
Measured: 3 days
Secondary outcomes (2)
weaning outcome
failed or succeeded liberation
Measured: 1 week
ICU stay
period of ICU stay
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Failure with HypoxiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Entsar Hsanen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746636
- Sponsor's protocol ID
- weaning from HVNI
- Acronym
- HVNI
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Four Weaning Methods from High-velocity Nasal Insufflation Device in Acute Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT06746636
- Acronym / sponsor ID
- HVNI / weaning from HVNI
- Conditions
- Respiratory Failure with Hypoxia
- Keywords
- HVNI, HFNC, HFNO, weaning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 24 Dec 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 oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters/ min of heated and fully humidified gas with a fraction of inspired oxygen (FIO2) ranging between 21% and 100% . High-flow nasal oxygen therapy has become an increasingly popular choice of therapy due to the potential complications of invasive ventilation and the frequent uncomfortable or life-threatening adverse effects that are produced in non-invasive ventilation (NIV) . The HFNO allows the modification of only two variables: the percentage of oxygen being delivered and the rate of gas flow . Numerous well-designed studies have been conducted into the use of the HFNC in the treatment of critically ill patients, and HFNC is now widely used in the treatment of patients with various diagnoses including acute hypoxemic respiratory failure or acute respiratory distress syndrome (ARDS) , and is used in post-extubation treatment, post-cardiothoracic surgery respiratory distress , and respiratory compromise induced by heart failure .
High-velocity nasal insufflation (HVNI) is a form of HFNC that utilizes a small bore nasal cannula to generate higher velocities of gas delivery than its counterparts using large bore HFNC. HVNI can accomplish a complete purge of extrathoracic dead space and may be able to provide ventilatory support in patients with acute hypercapnic respiratory failure in addition to oxygenation support.
This study is necessary because, even though studies were being conducted to determine both the optimal technique for HFNO delivery and the clinical setting in which it is most useful, the best strategy for weaning from HVNI remains unknown. It has also not been established at what point a patient should be considered stable enough to attempt for withdrawing the HVNI
Detailed description
High-flow nasal oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters/ min of heated and fully humidified gas with a fraction of inspired oxygen (FIO2) ranging between 21% and 100% . High-flow nasal oxygen therapy has become an increasingly popular choice of therapy due to the potential complications of invasive ventilation and the frequent uncomfortable or life-threatening adverse effects that are produced in non-invasive ventilation (NIV) . The HFNO allows the modification of only two variables: the percentage of oxygen being delivered and the rate of gas flow . Numerous well-designed studies have been conducted into the use of the HFNC in the treatment of critically ill patients, and HFNC is now widely used in the treatment of patients with various diagnoses including acute hypoxemic respiratory failure or acute respiratory distress syndrome (ARDS) , and is used in post-extubation treatment , post-cardiothoracic surgery respiratory distress , and respiratory compromise induced by heart failure.
High-velocity nasal insufflation (HVNI) is a form of HFNC that utilizes a small bore nasal cannula to generate higher velocities of gas delivery than its counterparts using large bore HFNC. HVNI can accomplish a complete purge of extrathoracic dead space and may be able to provide ventilatory support in patients with acute hypercapnic respiratory failure in addition to oxygenation support .
This study is necessary because, even though studies were being conducted to determine both the optimal technique for HFNO delivery and the clinical setting in which it is most useful, the best strategy for weaning from HVNI remains unknown. It has also not been established at what point a patient should be considered stable enough to attempt to start withdrawing the HVNI
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Flow reduction | Experimental | Device: High velocity nasal insufflationthe flow will gradually be reduced by 10 L/ min/h. When it reaches 20 L/min, FiO2 reduction will then begin at 0.1 /h until it reaches 0.3. |
| Oxygen reduction | Experimental | Device: High velocity nasal insufflationFiO2 will gradually be reduced by 0.1 /h until it reaches 0.3. At this point, the flow will be reduced by 10 L/min/h until it reaches 20 L/min. |
| Sudden reduction | Experimental | Device: High velocity nasal insufflationHVNI will be abruptly discontinued after fulfilling weaning criteria provided that flow and Fio2 are less than 40 L\min and 40% |
| Flow and oxygen reduction | Experimental | Device: High velocity nasal insufflationboth flow and FiO2 will be gradually reduced simultaneously at a rate of 10 L/min and 0.1 /h, respectively, until they reach 20 L/min for flow and 0.3 for FiO2 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- This study will include Patients over 18 years receiving respiratory support through HVNI for acute hypoxemic respiratory failure
- Those eligible for weaning according to European Respiratory Society weaning criteria
Key exclusion criteria (1 listed)
- Extensive facial trauma or burn II. Refusal to participate. III. Usual long-term treatment with NIV for chronic disease IV. Tracheotomy or other upper airway disorders
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 velocity nasal insufflation• HVNI was supplied using a Vapotherm Precision Flow [Precision Flow Plus, Vapotherm, INC. U.S.A. device]. | Device | Flow and oxygen reduction, Flow reduction, Oxygen reduction, Sudden reduction |
Primary outcome
Total weaning period (from the first time of being ready to wean till 48h after liberation of HVNI)
Time frame: 3 days
period taken for liberation from HVNI
2 secondary outcomes
weaning outcome
Time frame: 1 week
ICU stay
Time frame: 1month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing High velocity nasal insufflation in people with Respiratory Failure with Hypoxia, run by Assiut University.
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 2 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: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Entsar Hsanen Mohamed, lecturer (+201019968106, entsar.hsanen@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total weaning period (from the first time of being ready to wean till 48h after liberation of HVNI) (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2024.