Noninvasive Support Methods for Acute Respiratory Failure of Community-acquired Pneumonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Non-Invasive ventilation (NIV)
DeviceParticipants 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
DeviceParticipants 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 groups
100 Participants
are divided into 2 treatment groupsGroup A: Non-Invasive Ventilation (NIV)Experimental treatment 1 intervention
Group B: High velocity nasal insufflation (HVNI)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment Failure Within 48 Hours
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.
Time frame
48 hours after randomizationSponsors and contacts
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Source ClinicalTrials.gov