Noninvasive breathing support for severe community-acquired pneumonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.