Community-acquired Pneumonia, Community-Acquired Infections
Conditions
Keywords
CAP, NIV, HVNI
Brief 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.
Detailed 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.
Interventions
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.
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).
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
This is an open-label trial wherein participants, care providers, and investigators are aware of the assigned interventions. To minimize assessment bias, outcome assessors responsible for evaluating primary and secondary endpoints will remain blinded to treatment allocations throughout the study duration.
Intervention model description
This study is designed as a randomized, controlled, parallel-group clinical trial. Participants will be randomly assigned in a 1:1 ratio to receive either high-velocity nasal insufflation (HVNI) or noninvasive ventilation (NIV). Each participant will remain in their assigned intervention group for the duration of the study. The primary objective is to compare the efficacy of HVNI versus NIV in managing acute exacerbations of community-acquired pneumonia (CAP) by assessing treatment failure rates within 48 hours, defined as the need for intubation or death. Secondary outcomes include changes in gas exchange parameters, patient comfort levels, ICU length of stay, and 28-day mortality rates.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Failure Within 48 Hours | 48 hours after randomization | Treatment failure is defined as the occurrence of either endotracheal intubation or death within 48 hours following randomization. This composite endpoint assesses the immediate efficacy of the assigned respiratory support modality-High-Velocity Nasal Insufflation (HVNI) or Noninvasive Ventilation (NIV)-in preventing rapid clinical deterioration in patients with acute exacerbations of community-acquired pneumonia (CAP) accompanied by hypoxemic respiratory failure. |
Countries
Egypt
Contacts
Primary ContactAhmad M. Shaddad, MD
Outcome results
None listed