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

Assiut University

Status: Not yet enrolling

Conditions: Community-acquired Pneumonia; Community-Acquired Infections

Treatments: Device: High Velocity Nasal Insufflation; Device: Non-Invasive ventilation (NIV)

Study type: Interventional

Funder types: Other

Identifiers

NCT06996834

307052025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Non-Invasive Ventilation (NIV)

Experimental group

Description:

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).

Treatment:

Device: Non-Invasive ventilation (NIV)

High velocity nasal insufflation (HVNI)

Experimental group

Description:

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).

Treatment:

Device: High Velocity Nasal Insufflation