Weaning From Mechanical VentilationNCT07133698
High Flow Nasal Cannula Versus High Velocity Nasal Insufflation for Weaning
A study testing High Flow nasal Cannula, High velocity nasal insufflation and Noninvasive ventilation in people with Weaning From Mechanical Ventilation, run by Assiut University at 1 site in Egypt.
Trial summary
In intensive care units (ICUs), approximately 10% to 15%of patients ready to be separated from a ventilator experience extubation failure leading to reintubation. In patients considered at high risk, these rates can even exceed 20%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Weaning From Mechanical Ventilation
- What is being tested?
- High Flow nasal Cannula, High velocity nasal insufflation and Noninvasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Oct 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) intubated for >24 hours due to acute respiratory failure, identified as high-risk for extubation failure AND fulfilling standard readiness-to-wean criteria (e.g., resolution of cause of intubation, adequate gas exchange [P/F ≥150], hemodynamic stability, spontaneous breathing trial [SBT] success)
Who cannot join
- Patients with central nervous system disorders unrelated to hypercapnic encephalopathy or hypoxemia.
- Patients with post arrest encephalopathy.
- Patient with previous tracheotomy.
- Patients who received noninvasive ventilation without subsequent intubation.
- Patients with end organ failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Flow Nasal Cannula vs. High Velocity Nasal Insufflation for Weaning From Mechanical Ventilation in Respiratory ICU
In intensive care units (ICUs), approximately 10% to 15%of patients ready to be separated from a ventilator experience extubation failure leading to reintubation. In patients considered at high risk, these rates can even exceed 20%. Because reintubation is associated with particularly high mortality a strategy of oxygenation aimed at avoiding reintubation deserves consideration. Although noninvasive ventilation may prevent postextubation respiratory failure in patients at high risk only 2 small-scale randomized clinical trials (RCTs) have shown decreased reintubation rates compared with standard oxygen. The most recent international clinical practice guidelines recommend the use of noninvasive ventilation to prevent post extubation respiratory failure in patients at high risk of extubation failure (7). However, up until now, no large-scale RCT has demonstrated a significant reduction of reintubation rates with noninvasive ventilation compared with standard oxygen. Thereby, most patients are treated with standard oxygen in clinical practice and only10% of them receive noninvasive ventilation after extubation in the ICU.
High-flow nasal cannula (HFNC) oxygen therapy is a new type of respiratory support system which can supply high flow mixed gases through special nasal prongs at a sufficient temperature and humidity for patient comfort. Many studies have confirmed that the comfort and tolerance of HFNC is significantly higher than that of NIV. As an alternative to NIV, HFNC has been shown to be as efficacious as NIV in preventing post-extubation respiratory failure or re-intubation in patients with hypoxemic respiratory failure.
High-velocity nasal insufflation, a form of high-flow nasal cannula, focuses on optimum efficiency of the dead-space purge to augment ventilation (removal of carbon dioxide from the dead space between breaths), in addition to providing other effects of high-flow nasal cannula. This is accomplished by use of small-bore nasal cannulae (typically 2.7-mm internal diameter for adult patients) to produce high velocity flow that is approximately 360% greater than that of the larger bore cannulae used in previous studies. According to flow analyses8 and clinical experience, high velocity nasal insufflation typically requires a flow of 25 to 35 L/min in adults to accomplish a complete purge of the extrathoracic anatomic reservoir between breaths.
Read the detailed description
All patients were submitted to, History, Clinical examination, ABG, Laboratory assessment: as needed, ICU scores: APACHE II score.
Weaning from mechanical ventilation procedure:
The procedure of weaning from mechanical ventilation will be considered as early as possible. Patients who received mechanical ventilation >24 h will receive daily screening of subjective and objective indices for assessment of readiness to wean. Weaning will be conducted according to the statement of the ERS, ATS, ESICM, SCCM and SRLF.
Subjects who fulfill criteria for weaning readiness will be extubated and randomized in a ratio of 1:1:1 to either HVNI or HFNC or Noninvasive ventilation.
Weaning procedure will be considered successful when the spontaneous breathing is sustained for 48 consecutive hours without respiratory distress, with pH>7.35 and PaO2>60 mm Hg in a patient breathing through a mask at FiO2≤0.5.
The weaning outcome is considered a failure when death occurred within 48 hours of extubation. Initiation of mechanical ventilation within 48 hours of liberation from MV will be also considered to be a failure.
- Conditions
- Weaning From Mechanical Ventilation
- Being tested
- High Flow nasal Cannula, High velocity nasal insufflation, Noninvasive ventilation
- Keywords
- Weaning, HFNC, HVNI, Noninvasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow nasal CannulaDevice
Eligible subjects successfully passing a SBT will be extubated and immediately randomized (1:1:1) to receive one of the following post-extubation respiratory supports for ≥24 hours:
HVNI Arm: High-Velocity Nasal Insufflation (Flow: 40-60 L/min, FiO₂ titrated to SpO₂ ≥92%).
High velocity nasal insufflationDevice
HFNC Arm: High-Flow Nasal Cannula (Flow: 50-60 L/min, FiO₂ titrated to SpO₂ ≥92%).
Noninvasive ventilationDevice
NIV Arm: Non-Invasive Ventilation (Mode: [e.g., PSV], IPAP: [e.g., 8-12 cmH₂O], EPAP: [e.g., 4-6 cmH₂O], FiO₂ titrated to SpO₂ ≥92%) delivered via [e.g., oronasal mask] for ≥16 hours/day initially, with weaning per protocol.
| Study group | Role | What they receive |
|---|---|---|
| HFNC weaning | Experimental | HFNC Arm: High-Flow Nasal Cannula (Flow: 50-60 L/min, FiO₂ titrated to SpO₂ ≥92%). Receives: Device: High Flow nasal Cannula |
| HVNI weaning | Experimental | HVNI Arm: High-Velocity Nasal Insufflation (Flow: 40-60 L/min, FiO₂ titrated to SpO₂ ≥92%). Receives: Device: High velocity nasal insufflation |
| Noninvasive ventilation weaning | Active comparator | NIV Arm: Non-Invasive Ventilation (Mode: [e.g., PSV], IPAP: [e.g., 8-12 cmH₂O], EPAP: [e.g., 4-6 cmH₂O], FiO₂ titrated to SpO₂ ≥92%) delivered via [e.g., oronasal mask] for ≥16 hours/day initially, with weaning per protocol. Receives: Device: Noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful weaning
Weaning procedure will be considered successful when the spontaneous breathing is sustained for 48 consecutive hours without respiratory distress, with pH>7.35 and PaO2>60 mm Hg in a patient breathing through a mask at FiO2≤0.5
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Feb 2024
- Primary completion1 Sep 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Weaning From Mechanical VentilationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment: Each participant is assigned to only one of the three intervention groups (High flow nasal cannula weaning, High velocity nasal insufflation weaning, noninvasive ventilation weaning) for the entire duration of the weaning period. Outcomes are then compared between these groups.
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Gamal Elddin Khaleel, Assiut University
- Investigators
- waleed gamal elddin, ass. prof, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133698
- Sponsor's protocol ID
- WGEK-HVNI-HFNC
- Status last verified
- Jul 2026
- First submitted
- 14 Aug 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Longhini F, Pisani L, Lungu R, Comellini V, Bruni A, Garofalo E, Laura Vega M, Cammarota G, Nava S, Navalesi P. High-Flow Oxygen Therapy After Noninvasive Ventilation Interruption in Patients Recovering From Hypercapnic Acute Respiratory Failure: A Physiological Crossover Trial. Crit Care Med. 2019 Jun;47(6):e506-e511. doi: 10.1097/CCM.0000000000003740.
PubMed 30882477Doshi PB, Whittle JS, Dungan G 2nd, Volakis LI, Bublewicz M, Kearney J, Miller TL, Dodge D, Harsch MR, DeBellis R, Chambers KA. The ventilatory effect of high velocity nasal insufflation compared to non-invasive positive-pressure ventilation in the treatment of hypercapneic respiratory failure: A subgroup analysis. Heart Lung. 2020 Sep-Oct;49(5):610-615. doi: 10.1016/j.hrtlng.2020.03.008. Epub 2020 Apr 6.
PubMed 32273085
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula vs. High Velocity Nasal Insufflation for Weaning From Mechanical Ventilation in Respiratory ICU
- ClinicalTrials.gov ID
- NCT07133698
- Acronym / sponsor ID
- WGEK-HVNI-HFNC
- Conditions
- Weaning From Mechanical Ventilation
- Keywords
- Weaning, HFNC, HVNI, Noninvasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 21 Aug 2025 (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.
In intensive care units (ICUs), approximately 10% to 15%of patients ready to be separated from a ventilator experience extubation failure leading to reintubation. In patients considered at high risk, these rates can even exceed 20%. Because reintubation is associated with particularly high mortality a strategy of oxygenation aimed at avoiding reintubation deserves consideration. Although noninvasive ventilation may prevent postextubation respiratory failure in patients at high risk only 2 small-scale randomized clinical trials (RCTs) have shown decreased reintubation rates compared with standard oxygen. The most recent international clinical practice guidelines recommend the use of noninvasive ventilation to prevent post extubation respiratory failure in patients at high risk of extubation failure (7). However, up until now, no large-scale RCT has demonstrated a significant reduction of reintubation rates with noninvasive ventilation compared with standard oxygen. Thereby, most patients are treated with standard oxygen in clinical practice and only10% of them receive noninvasive ventilation after extubation in the ICU.
High-flow nasal cannula (HFNC) oxygen therapy is a new type of respiratory support system which can supply high flow mixed gases through special nasal prongs at a sufficient temperature and humidity for patient comfort. Many studies have confirmed that the comfort and tolerance of HFNC is significantly higher than that of NIV. As an alternative to NIV, HFNC has been shown to be as efficacious as NIV in preventing post-extubation respiratory failure or re-intubation in patients with hypoxemic respiratory failure.
High-velocity nasal insufflation, a form of high-flow nasal cannula, focuses on optimum efficiency of the dead-space purge to augment ventilation (removal of carbon dioxide from the dead space between breaths), in addition to providing other effects of high-flow nasal cannula. This is accomplished by use of small-bore nasal cannulae (typically 2.7-mm internal diameter for adult patients) to produce high velocity flow that is approximately 360% greater than that of the larger bore cannulae used in previous studies. According to flow analyses8 and clinical experience, high velocity nasal insufflation typically requires a flow of 25 to 35 L/min in adults to accomplish a complete purge of the extrathoracic anatomic reservoir between breaths.
Detailed description
All patients were submitted to, History, Clinical examination, ABG, Laboratory assessment: as needed, ICU scores: APACHE II score.
Weaning from mechanical ventilation procedure:
The procedure of weaning from mechanical ventilation will be considered as early as possible. Patients who received mechanical ventilation >24 h will receive daily screening of subjective and objective indices for assessment of readiness to wean. Weaning will be conducted according to the statement of the ERS, ATS, ESICM, SCCM and SRLF.
Subjects who fulfill criteria for weaning readiness will be extubated and randomized in a ratio of 1:1:1 to either HVNI or HFNC or Noninvasive ventilation.
Weaning procedure will be considered successful when the spontaneous breathing is sustained for 48 consecutive hours without respiratory distress, with pH>7.35 and PaO2>60 mm Hg in a patient breathing through a mask at FiO2≤0.5.
The weaning outcome is considered a failure when death occurred within 48 hours of extubation. Initiation of mechanical ventilation within 48 hours of liberation from MV will be also considered to be a failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel Assignment: Each participant is assigned to only one of the three intervention groups (High flow nasal cannula weaning, High velocity nasal insufflation weaning, noninvasive ventilation weaning) for the entire duration of the weaning period. Outcomes are then compared between these groups.
| Arm | Type | Receives |
|---|---|---|
| HFNC weaning | Experimental | Device: High Flow nasal CannulaHFNC Arm: High-Flow Nasal Cannula (Flow: 50-60 L/min, FiO₂ titrated to SpO₂ ≥92%). |
| HVNI weaning | Experimental | Device: High velocity nasal insufflationHVNI Arm: High-Velocity Nasal Insufflation (Flow: 40-60 L/min, FiO₂ titrated to SpO₂ ≥92%). |
| Noninvasive ventilation weaning | Active comparator | Device: Noninvasive ventilationNIV Arm: Non-Invasive Ventilation (Mode: [e.g., PSV], IPAP: [e.g., 8-12 cmH₂O], EPAP: [e.g., 4-6 cmH₂O], FiO₂ titrated to SpO₂ ≥92%) delivered via [e.g., oronasal mask] for ≥16 hours/day initially, with weaning per protocol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (≥18 years) intubated for >24 hours due to acute respiratory failure, identified as high-risk for extubation failure AND fulfilling standard readiness-to-wean criteria (e.g., resolution of cause of intubation, adequate gas exchange [P/F ≥150], hemodynamic stability, spontaneous breathing trial [SBT] success)
Key exclusion criteria (5 listed)
- Patients with central nervous system disorders unrelated to hypercapnic encephalopathy or hypoxemia.
- Patients with post arrest encephalopathy.
- Patient with previous tracheotomy.
- Patients who received noninvasive ventilation without subsequent intubation.
- Patients with end organ failure.
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 CannulaEligible subjects successfully passing a SBT will be extubated and immediately randomized (1:1:1) to receive one of the following post-extubation respiratory supports for ≥24 hours: HVNI Arm: High-Velocity Nasal Insufflation (Flow: 40-60 L/min, FiO₂ titrated to SpO₂ ≥92%). | Device | HFNC weaning |
| High velocity nasal insufflationHFNC Arm: High-Flow Nasal Cannula (Flow: 50-60 L/min, FiO₂ titrated to SpO₂ ≥92%). | Device | HVNI weaning |
| Noninvasive ventilationNIV Arm: Non-Invasive Ventilation (Mode: [e.g., PSV], IPAP: [e.g., 8-12 cmH₂O], EPAP: [e.g., 4-6 cmH₂O], FiO₂ titrated to SpO₂ ≥92%) delivered via [e.g., oronasal mask] for ≥16 hours/day initially, with weaning per protocol. | Device | Noninvasive ventilation weaning |
Primary outcome
Successful weaning
Time frame: 48 hours
Weaning procedure will be considered successful when the spontaneous breathing is sustained for 48 consecutive hours without respiratory distress, with pH>7.35 and PaO2>60 mm Hg in a patient breathing through a mask at FiO2≤0.5
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 9 Jul 2026.
- Background: PubMed 30882477Longhini F, Pisani L, Lungu R, Comellini V, Bruni A, Garofalo E, Laura Vega M, Cammarota G, Nava S, Navalesi P. High-Flow Oxygen Therapy After Noninvasive Ventilation Interruption in Patients Recovering From Hypercapnic Acute Respiratory Failure: A Physiological Crossover Trial. Crit Care Med. 2019 Jun;47(6):e506-e511. doi: 10.1097/CCM.0000000000003740.
- Background: PubMed 32273085Doshi PB, Whittle JS, Dungan G 2nd, Volakis LI, Bublewicz M, Kearney J, Miller TL, Dodge D, Harsch MR, DeBellis R, Chambers KA. The ventilatory effect of high velocity nasal insufflation compared to non-invasive positive-pressure ventilation in the treatment of hypercapneic respiratory failure: A subgroup analysis. Heart Lung. 2020 Sep-Oct;49(5):610-615. doi: 10.1016/j.hrtlng.2020.03.008. Epub 2020 Apr 6.
- 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.
waleed gamal elddin, ass. prof principal investigator
Assiut University
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 Cannula, High velocity nasal insufflation and Noninvasive ventilation in people with Weaning From Mechanical Ventilation, run by Assiut University at 1 site in Egypt.
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 5 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 9 Jul 2026. 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 Egypt. 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?
Successful weaning (time frame: 48 hours). 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 NCT07133698, which also lists 2 linked publications.
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 9 Jul 2026.