Noninvasive breathing support for severe community-acquired pneumonia
A Randomized Controlled Trial of High-Velocity Nasal Insufflation (HVNI) Versus Noninvasive Ventilation (NIV) for Acute Respiratory Failure of Community-Acquired Pneumonia (CAP).
This trial tests whether high-velocity nasal insufflation (HVNI) or standard noninvasive ventilation (NIV) better helps adults with community-acquired pneumonia and low oxygen levels avoid intubation or death within 48 hours.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut, Assuit) |
| Trial ID | NCT06996834 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, open-label, parallel-group trial enrolling 100 adults with community-acquired pneumonia (CAP) who develop hypoxemic respiratory failure. Participants are randomly assigned to receive either high-velocity nasal insufflation (HVNI) or standard noninvasive ventilation (NIV) as initial respiratory support. The primary outcome is treatment failure within 48 hours, defined as need for endotracheal intubation or death; secondary outcomes include arterial blood gas changes, patient comfort scores, ICU length of stay, and 28-day mortality. The trial excludes patients with hemodynamic instability requiring vasopressors, altered mental status (GCS <13), contraindications to noninvasive support, or a Do-Not-Intubate order.
Who should consider this trial
Good fit: Adults aged 18 or older with clinical and radiographic CAP who have hypoxemic respiratory failure (PaO2/FiO2 ≤ 300 mmHg or respiratory rate ≥ 25/min) and can provide informed consent are ideal candidates.
Not a fit: Patients who are hemodynamically unstable, have impaired consciousness, facial trauma or recent upper airway surgery, or a Do-Not-Intubate order would not be expected to benefit or are excluded from participation.
Why it matters
Potential benefit: If successful, HVNI could reduce the need for intubation, improve patient comfort, and shorten ICU stays for adults with CAP-related respiratory failure.
How similar studies have performed: High-flow nasal oxygen therapies have shown benefit in some forms of hypoxemic respiratory failure, but direct randomized comparisons of HVNI versus standard NIV specifically in CAP are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Asyut, Assuit
- Assuit University — Asyut, Assuit, Egypt (Recruiting)
Study contacts
- Principal investigator: Ahmad M. Shaddad, MD — Assiut University
- Study coordinator: Ahmad M. Shaddad, MD
- Email: shaddad_ahmad@yahoo.com
- Phone: +0201111171930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.