NCT07381712

High-Flow Nasal Cannula Versus Non-Invasive Ventilation for Acute Respiratory Failure in Pulmonary Embolism.

High-Flow Nasal Cannula Versus Non-Invasive Ventilation for Acute Respiratory Failure in Pulmonary Embolism: A Randomized Controlled Trial on Weaning Success and Survival"

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Acute pulmonary embolism (PE) often causes hypoxemic respiratory failure through ventilation-perfusion mismatch and right-ventricular (RV) strain; supportive oxygenation plus prompt anticoagulation are crucial to care . Current guidelines advise supplemental oxygen and escalation according to hemodynamic/respiratory status, but do not identify an optimal noninvasive modality for PE-related respiratory failure.

Detailed description

Acute pulmonary embolism (PE) often causes hypoxemic respiratory failure through ventilation-perfusion mismatch and right-ventricular (RV) strain; supportive oxygenation plus prompt anticoagulation are crucial to care . Current guidelines advise supplemental oxygen and escalation according to hemodynamic/respiratory status, but do not identify an optimal noninvasive modality for PE-related respiratory failure .. Non-invasive ventilation (NIV) can correct hypoxemia, yet applied positive pressure may adversely affect RV preload/afterload in PE and is frequently limited by intolerance . High-flow nasal cannula (HFNC) provides heated, humidified flows up to 60 L/min, improves oxygenation, reduces work of breathing, and enhances comfort versus conventional oxygen; in general hypoxemic acute respiratory failure (AHRF), HFNC reduced escalation and intubation compared with standard oxygen and, in some analyses, performed at least as well as NIV . Evidence specific to PE is emerging: a retrospective cohort and case series reported rapid improvements in oxygenation and respiratory distress with HFNC, with good tolerance and no major hemodynamic compromise. By avoiding mask-related intolerance and reducing harmful intrathoracic pressure effects while delivering consistent high FiO₂ and modest PEEP, HFNC may facilitate faster de-escalation and better outcomes than NIV in PE-related AHRF, a population for whom definitive comparative trials are lacking.

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
DEVICE	High-Flow Nasal Cannula (HFNC)	Patients randomized to the HFNC arm will receive heated, humidified oxygen at flow rates up to 60 L/min, with FiO₂ titrated to maintain SpO₂ within the target range (92-96%).
DEVICE	Non-Invasive Ventilation (NIV)	In the NIV arm, BiPAP devices will be used with an oronasal mask interface, adjusting inspiratory and expiratory pressures according to patient tolerance and ABG results.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-10-30
• Completion: 2026-11-30
• First posted: 2026-02-02
• Last updated: 2026-02-02

Locations

1 site across 1 country: Egypt