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A Randomized Controlled Trial of High-Velocity Nasal Insufflation (HVNI) Versus Noninvasive Ventilation (NIV) for Acute Respiratory Failure of Community-Acquired Pneumonia (CAP).

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Egypt
Assuit University
RECRUITING
Asyut
Contact Information
Primary
Ahmad M. Shaddad, MD
shaddad_ahmad@yahoo.com
+0201111171930
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 100
Treatments
Experimental: Non-Invasive Ventilation (NIV)
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).
Experimental: High velocity nasal insufflation (HVNI)
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).
Related Therapeutic Areas
Sponsors
Leads: Assiut University

This content was sourced from clinicaltrials.gov