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RECRUITING Not applicable ClinicalTrials.gov

Noninvasive Support Methods for Acute Respiratory Failure of Community-acquired Pneumonia

Sponsor: Assiut University • ClinicalTrials.gov ID: NCT06996834

Registry updated: 2026-09-22
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Description

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.

Interventions

  • Non-Invasive ventilation (NIV) (Device)
    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 Insufflation (Device)
    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).

Eligibility 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

Conditions

Community-acquired Pneumonia Community-Acquired Infections

Locations

  • Assuit University — Asyut, Assuit, Egypt
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record