Extubation FailureNIV-HFNCNCT07630766
Noninvasive Ventilation Versus High-Flow Nasal Cannula After Extubation in High-Risk ICU Patients
A study testing NIV and HFNC in people with Extubation Failure, run by Benha University at 1 site in Egypt.
Trial summary
Extubation failure is associated with increased morbidity and mortality in critically ill patients. High-risk patients may benefit from preventive respiratory support after extubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation Failure
- What is being tested?
- NIV and HFNC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2025to 15 May 2026
- 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.
- Received invasive mechanical ventilation for at least 24 hours.
- Considered ready for planned extubation after successful completion of a spontaneous breathing trial.
- High risk of extubation failure, defined by the presence of at least four of the following risk factors:
- Age >65 years. APACHE II score >12 on the day of extubation. Body mass index >30 kg/m². Inadequate secretion management. Difficult or prolonged weaning. Two or more comorbidities. Acute heart failure requiring mechanical ventilation. Moderate-to-severe chronic obstructive pulmonary disease. Airway patency problems. Prolonged mechanical ventilation. Hypercapnia at the end of the spontaneous breathing trial.
Who cannot join
- Age <18 years.
- Presence of a tracheostomy.
- Accidental extubation.
- Self-extubation.
- Contraindication to noninvasive ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Noninvasive Ventilation and High Flow Nasal Cannula in Patients With High Risk of Extubation Failure
Extubation failure is associated with increased morbidity and mortality in critically ill patients. High-risk patients may benefit from preventive respiratory support after extubation. This randomized controlled trial compared noninvasive ventilation (NIV) with high-flow nasal cannula (HFNC) in adult intensive care unit (ICU) patients at high risk of extubation failure. The study evaluated reintubation rates, time to reintubation, physiological parameters, complications, and clinical outcomes following planned extubation. The aim was to determine the optimal post-extubation respiratory support strategy for reducing extubation failure in high-risk ICU patients.
- Conditions
- Extubation Failure
- Being tested
- NIV, HFNC
- Keywords
- Noninvasive ventilation, high-flow nasal cannula, extubation failure, reintubation, ICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIVDevice
NIV was initiated immediately after extubation using bilevel positive airway pressure delivered via a properly fitted face mask with active humidification using a Dräger Savina 300 ventilator (Drägerwerk AG \& Co. KGaA, Lübeck, Germany). Ventilator settings were adjusted to achieve a respiratory rate <26 breaths/min, tidal volume of 6-8 mL/kg predicted body weight, and adequate oxygenation (SpO₂ ≥92%, pH ≥7.35). Sedation was not permitted.
HFNCDevice
HFNC was applied immediately after extubation using a heated humidified high-flow nasal cannula system (BioVent A-Series, Model: BioHF BB60101; BIO-AOI, Cairo, Egypt). Flow was initially set at 10 L/min and titrated up to 60 L/min according to patient tolerance. Gas temperature was maintained at 37°C.
In both groups, FiO₂ was adjusted to maintain SpO₂ ≥92%. After 48 hours, respiratory support was discontinued and conventional oxygen therapy was provided if required. Rescue NIV was not allowed in the HFNC group. All patients received standardized care.
| Study group | Role | What they receive |
|---|---|---|
| NIV | Experimental | Patients received noninvasive ventilation immediately after planned extubation according to the study protocol. Receives: Device: NIV |
| HFNC | Active comparator | Patients received high-flow nasal cannula oxygen therapy immediately after planned extubation according to the study protocol. Receives: Device: HFNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintubation Rate
Proportion of patients requiring reintubation following planned extubation.
Measured: 7 days
Secondary outcomes (1)
Time to Reintubation
Time elapsed from extubation to reintubation among patients requiring reintubation.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start30 Jul 2025
- Primary completion30 Apr 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extubation FailureStudies of the same condition, open and under way.
- More trials run by Benha 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
- Participants were randomly assigned in a parallel-group design to receive either noninvasive ventilation (NIV) or high-flow nasal cannula (HFNC) immediately after planned extubation. Outcomes were compared between the two groups during follow-up.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koot Ahmad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630766
- Sponsor's protocol ID
- RC.16.7.2025
- Acronym
- NIV-HFNC
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Noninvasive Ventilation and High Flow Nasal Cannula in Patients With High Risk of Extubation Failure
- ClinicalTrials.gov ID
- NCT07630766
- Acronym / sponsor ID
- NIV-HFNC / RC.16.7.2025
- Conditions
- Extubation Failure
- Keywords
- Noninvasive ventilation, high-flow nasal cannula, extubation failure, reintubation, ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 5 Jun 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.
Extubation failure is associated with increased morbidity and mortality in critically ill patients. High-risk patients may benefit from preventive respiratory support after extubation. This randomized controlled trial compared noninvasive ventilation (NIV) with high-flow nasal cannula (HFNC) in adult intensive care unit (ICU) patients at high risk of extubation failure. The study evaluated reintubation rates, time to reintubation, physiological parameters, complications, and clinical outcomes following planned extubation. The aim was to determine the optimal post-extubation respiratory support strategy for reducing extubation failure in high-risk ICU patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a parallel-group design to receive either noninvasive ventilation (NIV) or high-flow nasal cannula (HFNC) immediately after planned extubation. Outcomes were compared between the two groups during follow-up.
| Arm | Type | Receives |
|---|---|---|
| NIV | Experimental | Device: NIVPatients received noninvasive ventilation immediately after planned extubation according to the study protocol. |
| HFNC | Active comparator | Device: HFNCPatients received high-flow nasal cannula oxygen therapy immediately after planned extubation according to the study protocol. |
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.
- Received invasive mechanical ventilation for at least 24 hours.
- Considered ready for planned extubation after successful completion of a spontaneous breathing trial.
- High risk of extubation failure, defined by the presence of at least four of the following risk factors:
- Age >65 years. APACHE II score >12 on the day of extubation. Body mass index >30 kg/m². Inadequate secretion management. Difficult or prolonged weaning. Two or more comorbidities. Acute heart failure requiring mechanical ventilation. Moderate-to-severe chronic obstructive pulmonary disease. Airway patency problems. Prolonged mechanical ventilation. Hypercapnia at the end of the spontaneous breathing trial.
Key exclusion criteria (5 listed)
- Age <18 years.
- Presence of a tracheostomy.
- Accidental extubation.
- Self-extubation.
- Contraindication to noninvasive ventilation.
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 |
|---|---|---|
| NIVNIV was initiated immediately after extubation using bilevel positive airway pressure delivered via a properly fitted face mask with active humidification using a Dräger Savina 300 ventilator (Drägerwerk AG \& Co. KGaA, Lübeck, Germany). Ventilator settings were adjusted to achieve a respiratory rate <26 breaths/min, tidal volume of 6-8 mL/kg predicted body weight, and adequate oxygenation (SpO₂ ≥92%, pH ≥7.35). Sedation was not permitted. | Device | NIV |
| HFNCHFNC was applied immediately after extubation using a heated humidified high-flow nasal cannula system (BioVent A-Series, Model: BioHF BB60101; BIO-AOI, Cairo, Egypt). Flow was initially set at 10 L/min and titrated up to 60 L/min according to patient tolerance. Gas temperature was maintained at 37°C. In both groups, FiO₂ was adjusted to maintain SpO₂ ≥92%. After 48 hours, respiratory support was discontinued and conventional oxygen therapy was provided if required. Rescue NIV was not allowed in the HFNC group. All patients received standardized care. | Device | HFNC |
Primary outcome
Reintubation Rate
Time frame: 7 days
Proportion of patients requiring reintubation following planned extubation.
1 secondary outcome
Time to Reintubation
Time frame: 7 days
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 11 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIV and HFNC in people with Extubation Failure, run by Benha 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 5 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 11 Jun 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?
Reintubation Rate (time frame: 7 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 11 Jun 2026.