RecruitingNot ApplicableNCT06996834

Noninvasive Support Methods for Acute Respiratory Failure of 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).

Sponsor

Assiut University

Enrollment

100 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Community-acquired Pneumonia Community-Acquired Infections

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. 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria4

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

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Interventions

DEVICENon-Invasive ventilation (NIV)

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.

DEVICEHigh Velocity Nasal Insufflation

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).