High Velocity Nasal InsufflationNCT07383051
A Randomized Clinical Trial for Predictors of Successful Extubation of Pediatric Patients With or Without High Velocity Nasal Insufflation
A study testing Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen and comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients in people with High Velocity Nasal Insufflation and Simple Oxygen, run by Cairo University at 1 site in Egypt.
Trial summary
A randomized clinical trial about predictors of successful extubation of pediatric patients from mechanical ventilation either on High Velocity Nasal Insufflation or simple nasal oxygen and comparing the outcome Read more about this study
- Who is it for?
- Ages 2 months to 13 years
- Conditions the study is for
- High Velocity Nasal Insufflation, Simple Oxygen, Weaning Criteria
- What is being tested?
- Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen and comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2025to 20 Mar 2027
- 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 2 months to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 2 months and 13 years old with minimum weight 4kg
- Both sexes
- Patients on mechanical ventilation for at least 24 hours for any indication
Who cannot join
- Patients not ready for weaning from mechanical ventilation
- Contraindications to use of High velocity nasal insufflation
- Prolonged mechanical ventilation for more than 21 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, Cairo Governorate
Cairo University Cairo University
About this study
Official title: Predictors of Successful Extubation of Pediatric Patients From Mechanical Ventilation With or Without Post Extubation High Velocity Nasal Insufflation
A randomized clinical trial about predictors of successful extubation of pediatric patients from mechanical ventilation either on High Velocity Nasal Insufflation or simple nasal oxygen and comparing the outcome
Read the detailed description
A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or re-intubation within 48 hours, presence of respiratory distress or stridor post extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality.
- Being tested
- Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen, comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygenDevice
A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or re-intubation within 48 hours, presence of respiratory distress or stridor post extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality.
comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patientsDevice
A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or re-intubation within 48 hours, presence of respiratory distress or stridor post extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality.
| Study group | Role | What they receive |
|---|---|---|
| Exubation of pediatric patients on High Velocity Nasal Insufflation | Experimental | Not described Receives: Device: Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen; Device: comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients |
| Exubation of pediatric patients on simple oxygen | Active comparator | Not described Receives: Device: Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen; Device: comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing the need for reintubation within 48 hours afterr extubation using High Velocity Nasal Insufflation versus simple oxygen
Successful extubation with no need for reintubation within 48 hours among pediatric ICU patients in those using High Velocity Nasal Insufflation versus simple oxygen
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 posted3 Feb 2026
- Study start20 Sep 2025
- Primary completion20 Mar 2027 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Velocity Nasal InsufflationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- comparing the outcome between High Velocity Nasal Insufflation and simple oxygen after successful weaning from mechanical ventilation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherin Tarek Fayez Ali, Cairo University
- Investigators
- Cairo University Cairo University, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383051
- Sponsor's protocol ID
- MD-299-2025
- Status last verified
- Mar 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared as per the individual signed consent to participate.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Successful Extubation of Pediatric Patients From Mechanical Ventilation With or Without Post Extubation High Velocity Nasal Insufflation
- ClinicalTrials.gov ID
- NCT07383051
- Acronym / sponsor ID
- MD-299-2025
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 3 Feb 2026 (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.
A randomized clinical trial about predictors of successful extubation of pediatric patients from mechanical ventilation either on High Velocity Nasal Insufflation or simple nasal oxygen and comparing the outcome
Detailed description
A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or re-intubation within 48 hours, presence of respiratory distress or stridor post extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- comparing the outcome between High Velocity Nasal Insufflation and simple oxygen after successful weaning from mechanical ventilation
| Arm | Type | Receives |
|---|---|---|
| Exubation of pediatric patients on High Velocity Nasal Insufflation | Experimental | Device: Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen, Device: comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients |
| Exubation of pediatric patients on simple oxygen | Active comparator | Device: Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen, Device: comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients |
Who may qualify
- Ages
- 2 months to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 2 months and 13 years old with minimum weight 4kg
- Both sexes
- Patients on mechanical ventilation for at least 24 hours for any indication
Key exclusion criteria (3 listed)
- Patients not ready for weaning from mechanical ventilation
- Contraindications to use of High velocity nasal insufflation
- Prolonged mechanical ventilation for more than 21 days
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 |
|---|---|---|
| Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygenA randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or re-intubation within 48 hours, presence of respiratory distress or stridor post extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality. | Device | Exubation of pediatric patients on High Velocity Nasal Insufflation, Exubation of pediatric patients on simple oxygen |
| comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patientsA randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or re-intubation within 48 hours, presence of respiratory distress or stridor post extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality. | Device | Exubation of pediatric patients on High Velocity Nasal Insufflation, Exubation of pediatric patients on simple oxygen |
Primary outcome
comparing the need for reintubation within 48 hours afterr extubation using High Velocity Nasal Insufflation versus simple oxygen
Time frame: 48 hours
Successful extubation with no need for reintubation within 48 hours among pediatric ICU patients in those using High Velocity Nasal Insufflation versus simple oxygen
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 3 Nov 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared as per the individual signed consent to participate.
Related trials for High Velocity Nasal Insufflation
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Management of Post-operative Respiratory Failure by Using NIV and High Velocity Nasal Insufflation (HVNI)
Respiratory Failure Without Hypercapnia, Respiratory Failure With Hypercapnia
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Noninvasive Support Methods for Acute Respiratory Failure of Community-acquired Pneumonia
Community-acquired Pneumonia, Community-Acquired Infections
Recruiting
Noninvasive Support for Acute Respiratory Failure in Guillain-Barré Syndrome
Guillain-Barre Syndrome
Not yet recruiting
HVNI vs NIPPV in Type 2 Respiratory Failure
Respiratory Failure, Hypoxia
Not yet recruiting
Comparison Between Four Weaning Methods from High-velocity Nasal Insufflation Device in Acute Hypoxemic Respiratory Failure
Respiratory Failure with Hypoxia
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.
Cairo University Cairo University principal investigator
Cairo 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 Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen and comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients in people with High Velocity Nasal Insufflation and Simple Oxygen, run by Cairo 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 3 Nov 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?
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 Sherin T. Fayez Ali, PICU doctor (+01153576707, tareksherin16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing the need for reintubation within 48 hours afterr extubation using High Velocity Nasal Insufflation versus simple oxygen (time frame: 48 hours). 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 3 Nov 2026.