Community-acquired PneumoniaNCT06996834
Noninvasive Support Methods for Acute Respiratory Failure of Community-acquired Pneumonia
A study testing Non-Invasive ventilation (NIV) and High Velocity Nasal Insufflation in people with Community-acquired Pneumonia and Community-Acquired Infections, run by Assiut University at 1 site in Egypt.
Trial summary
This randomized controlled trial aims to compare the efficacy and safety of high-velocity nasal insufflation (HVNI) versus standard noninvasive ventilation (NIV) in adult patients experiencing acute exacerbations of community-acquired pneumonia (CAP) accompanied by hypoxemic respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia, Community-Acquired Infections
- What is being tested?
- Non-Invasive ventilation (NIV) and High Velocity Nasal Insufflation
- 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
- 1 Jul 2025to 1 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Clinical and radiographic diagnosis of CAP
- Respiratory failure using partial pressure of oxygen (PaO₂) and fraction of inspired oxygen (FiO₂) is defined by a partial pressure of oxygen/fraction of inspired oxygen ratio (PaO₂/FiO₂) ≤ 300 mmHg or a respiratory rate (RR) ≥ 25/min
- Informed consent obtained
Who cannot join
- Hemodynamic instability requiring vasopressors
- Altered mental status Glasgow Coma Scale (GCS < 13)
- Contraindication to NIV or HVNI (facial trauma, recent upper airway surgery)
- Do-Not-Intubate (DNI) order
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
Assuit University
Asyut, Assuit, 71515
Ahmad M. Shaddad, MD, +201111171930, shaddad_ahmad@yahoo.com
Ahmad M. Shaddad, MD
About this study
Official title: A Randomized Controlled Trial of High-Velocity Nasal Insufflation (HVNI) Versus Noninvasive Ventilation (NIV) for Acute Respiratory Failure of Community-Acquired Pneumonia (CAP).
This randomized controlled trial aims to compare the efficacy and safety of high-velocity nasal insufflation (HVNI) versus standard noninvasive ventilation (NIV) in adult patients experiencing acute exacerbations of community-acquired pneumonia (CAP) accompanied by hypoxemic respiratory failure. The primary focus is on assessing treatment failure within 48 hours, defined as the need for intubation or death. Secondary outcomes include evaluations of gas exchange parameters, patient comfort levels, duration of ICU stay, and 28-day mortality rates.
Read the detailed description
Community-acquired pneumonia (CAP) is a significant contributor to acute hypoxemic respiratory failure, often necessitating ventilatory support. Noninvasive ventilation (NIV) has been a conventional approach; however, it can be associated with patient discomfort and varying success rates. High-velocity nasal insufflation (HVNI) presents an alternative, delivering heated and humidified oxygen at high flow rates, which may improve oxygenation and patient tolerance.
This study is designed as a prospective, randomized, open-label, parallel-group trial involving 100 adult patients diagnosed with CAP-induced hypoxemic respiratory failure. Participants will be randomly assigned to receive either high-volume non-invasive ventilation (HVNI) or non-invasive ventilation (NIV). The primary endpoint is treatment failure within 48 hours post-randomization, characterized by the necessity for endotracheal intubation or mortality. Secondary endpoints encompass changes in arterial blood gas measurements, patient-reported comfort scores, length of ICU stay, and 28-day mortality rates.
By systematically comparing HVNI and NIV in this patient population, the study seeks to determine whether HVNI offers a viable and potentially superior alternative to traditional NIV methods in managing acute respiratory failure due to CAP.
- Being tested
- Non-Invasive ventilation (NIV), High Velocity Nasal Insufflation
- Keywords
- CAP, NIV, HVNI
- Medical subject headings
- Community-Acquired Pneumonia, Community-Acquired Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive ventilation (NIV)Device
Also called BI-level Positive airway pressure ventilation (BIPAP)
Participants in this arm will receive noninvasive ventilation using bilevel positive airway pressure (BiPAP) delivered via a full-face mask to support ventilation in patients with acute hypoxemic respiratory failure due to CAP.
High Velocity Nasal InsufflationDevice
Also called High velocity nasal cannula, Vapotherm delivery system
Participants in this arm will receive high-velocity nasal insufflation therapy, a type of high-flow nasal cannula (HFNC) therapy that delivers heated and humidified oxygen at high flow rates to support patients with acute hypoxemic respiratory failure resulting from community-acquired pneumonia (CAP).
| Study group | Role | What they receive |
|---|---|---|
| Non-Invasive Ventilation (NIV) | Experimental | Intervention:
Participants in this arm will receive non-invasive ventilation using bilevel positive airway pressure (BiPAP) delivered via a full-face mask to support ventilation in patients with acute hypoxemic respiratory failure due to community-acquired pneumonia (CAP). Receives: Device: Non-Invasive ventilation (NIV) |
| High velocity nasal insufflation (HVNI) | Experimental | Intervention:
Participants in this arm will receive high-velocity nasal insufflation therapy, a type of high-flow nasal cannula (HFNC) therapy that delivers heated and humidified oxygen at high flow rates to support patients with acute hypoxemic respiratory failure resulting from community-acquired pneumonia (CAP). Receives: Device: High Velocity Nasal Insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failure Within 48 Hours
Treatment failure is defined as the occurrence of either endotracheal intubation or death within 48 hours following randomization. This composite endpoint assesses the immediate efficacy of the assigned respiratory support modality-High-Velocity Nasal Insufflation (HVNI) or Noninvasive Ventilation (NIV)-in preventing rapid clinical deterioration in patients with acute exacerbations of community-acquired pneumonia (CAP) accompanied by hypoxemic respiratory failure.
Measured: 48 hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Jul 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies 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
- Model description
- This study is designed as a randomized, controlled, parallel-group clinical trial. Participants will be randomly assigned in a 1:1 ratio to receive either high-velocity nasal insufflation (HVNI) or noninvasive ventilation (NIV). Each participant will remain in their assigned intervention group for the duration of the study. The primary objective is to compare the efficacy of HVNI versus NIV in managing acute exacerbations of community-acquired pneumonia (CAP) by assessing treatment failure rates within 48 hours, defined as the need for intubation or death. Secondary outcomes include changes in gas exchange parameters, patient comfort levels, ICU length of stay, and 28-day mortality rates.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Shaddad, Assiut University
- Investigators
- Ahmad M. Shaddad, MD, Principal investigator, Assiut UniversityAliae A. Hussien, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996834
- Sponsor's protocol ID
- 307052025
- Status last verified
- Sep 2026
- First submitted
- 21 May 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan Description: De-identified individual participant data supporting the primary and secondary outcomes, along with accompanying data dictionaries and the statistical analysis plan, will be made available in accordance with Assiut University's institutional data-sharing policies.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of High-Velocity Nasal Insufflation (HVNI) Versus Noninvasive Ventilation (NIV) for Acute Respiratory Failure of Community-Acquired Pneumonia (CAP).
- ClinicalTrials.gov ID
- NCT06996834
- Acronym / sponsor ID
- 307052025
- Keywords
- CAP, NIV, HVNI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 30 May 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.
This randomized controlled trial aims to compare the efficacy and safety of high-velocity nasal insufflation (HVNI) versus standard noninvasive ventilation (NIV) in adult patients experiencing acute exacerbations of community-acquired pneumonia (CAP) accompanied by hypoxemic respiratory failure. The primary focus is on assessing treatment failure within 48 hours, defined as the need for intubation or death. Secondary outcomes include evaluations of gas exchange parameters, patient comfort levels, duration of ICU stay, and 28-day mortality rates.
Detailed description
Community-acquired pneumonia (CAP) is a significant contributor to acute hypoxemic respiratory failure, often necessitating ventilatory support. Noninvasive ventilation (NIV) has been a conventional approach; however, it can be associated with patient discomfort and varying success rates. High-velocity nasal insufflation (HVNI) presents an alternative, delivering heated and humidified oxygen at high flow rates, which may improve oxygenation and patient tolerance.
This study is designed as a prospective, randomized, open-label, parallel-group trial involving 100 adult patients diagnosed with CAP-induced hypoxemic respiratory failure. Participants will be randomly assigned to receive either high-volume non-invasive ventilation (HVNI) or non-invasive ventilation (NIV). The primary endpoint is treatment failure within 48 hours post-randomization, characterized by the necessity for endotracheal intubation or mortality. Secondary endpoints encompass changes in arterial blood gas measurements, patient-reported comfort scores, length of ICU stay, and 28-day mortality rates.
By systematically comparing HVNI and NIV in this patient population, the study seeks to determine whether HVNI offers a viable and potentially superior alternative to traditional NIV methods in managing acute respiratory failure due to CAP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a randomized, controlled, parallel-group clinical trial. Participants will be randomly assigned in a 1:1 ratio to receive either high-velocity nasal insufflation (HVNI) or noninvasive ventilation (NIV). Each participant will remain in their assigned intervention group for the duration of the study. The primary objective is to compare the efficacy of HVNI versus NIV in managing acute exacerbations of community-acquired pneumonia (CAP) by assessing treatment failure rates within 48 hours, defined as the need for intubation or death. Secondary outcomes include changes in gas exchange parameters, patient comfort levels, ICU length of stay, and 28-day mortality rates.
| Arm | Type | Receives |
|---|---|---|
| Non-Invasive Ventilation (NIV) | Experimental | Device: Non-Invasive ventilation (NIV)Intervention: Participants in this arm will receive non-invasive ventilation using bilevel positive airway pressure (BiPAP) delivered via a full-face mask to support ventilation in patients with acute hypoxemic respiratory failure due to community-acquired pneumonia (CAP). |
| High velocity nasal insufflation (HVNI) | Experimental | Device: High Velocity Nasal InsufflationIntervention: Participants in this arm will receive high-velocity nasal insufflation therapy, a type of high-flow nasal cannula (HFNC) therapy that delivers heated and humidified oxygen at high flow rates to support patients with acute hypoxemic respiratory failure resulting from community-acquired pneumonia (CAP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Clinical and radiographic diagnosis of CAP
- Respiratory failure using partial pressure of oxygen (PaO₂) and fraction of inspired oxygen (FiO₂) is defined by a partial pressure of oxygen/fraction of inspired oxygen ratio (PaO₂/FiO₂) ≤ 300 mmHg or a respiratory rate (RR) ≥ 25/min
- Informed consent obtained
Key exclusion criteria (4 listed)
- Hemodynamic instability requiring vasopressors
- Altered mental status Glasgow Coma Scale (GCS < 13)
- Contraindication to NIV or HVNI (facial trauma, recent upper airway surgery)
- Do-Not-Intubate (DNI) order
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 |
|---|---|---|
| Non-Invasive ventilation (NIV)Also: BI-level Positive airway pressure ventilation (BIPAP)Participants in this arm will receive noninvasive ventilation using bilevel positive airway pressure (BiPAP) delivered via a full-face mask to support ventilation in patients with acute hypoxemic respiratory failure due to CAP. | Device | Non-Invasive Ventilation (NIV) |
| High Velocity Nasal InsufflationAlso: High velocity nasal cannula, Vapotherm delivery systemParticipants in this arm will receive high-velocity nasal insufflation therapy, a type of high-flow nasal cannula (HFNC) therapy that delivers heated and humidified oxygen at high flow rates to support patients with acute hypoxemic respiratory failure resulting from community-acquired pneumonia (CAP). | Device | High velocity nasal insufflation (HVNI) |
Primary outcome
Treatment Failure Within 48 Hours
Time frame: 48 hours after randomization
Treatment failure is defined as the occurrence of either endotracheal intubation or death within 48 hours following randomization. This composite endpoint assesses the immediate efficacy of the assigned respiratory support modality-High-Velocity Nasal Insufflation (HVNI) or Noninvasive Ventilation (NIV)-in preventing rapid clinical deterioration in patients with acute exacerbations of community-acquired pneumonia (CAP) accompanied by hypoxemic respiratory failure.
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 22 Sep 2026.
- Individual participant dataSharing planned: Yes. Plan Description: De-identified individual participant data supporting the primary and secondary outcomes, along with accompanying data dictionaries and the statistical analysis plan, will be made available in accordance with Assiut University's institutional data-sharing policies.
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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.
Ahmad M. Shaddad, MD principal investigator
Assiut University
Aliae A. Hussien, MD 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 Non-Invasive ventilation (NIV) and High Velocity Nasal Insufflation in people with Community-acquired Pneumonia and Community-Acquired Infections, 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 4 inclusion and 4 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 22 Sep 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 Ahmad M. Shaddad, MD (+0201111171930, shaddad_ahmad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Failure Within 48 Hours (time frame: 48 hours after randomization). 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 22 Sep 2026.