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

Assiut University

Status: Active, not recruiting

Conditions: Pulmonary Embolism

Treatments: Device: Non-Invasive Ventilation (NIV); Device: High-Flow Nasal Cannula (HFNC)

Study type: Interventional

Funder types: Other

Identifiers

NCT07381712

HFNCvs NIV in PE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

- 1. Age ≥18 y; presented with acute PE confirmed by CTPA or high-probability V/Q.

2. AHRF needing non-invasive support; provided that patients able to protect airway and hemodynamically stable without escalating vasopressors

Exclusion criteria

• 1. Immediate indication for intubation; high-risk (massive) PE with shock requiring advanced airway/vasopressors; active major bleeding; untreated pneumothorax.

  2. Contraindications/intolerance to assigned modality (e.g., facial trauma for NIV; complete nasal obstruction for HFNC).

  3. Do-Not-Intubate orders; pregnancy ; concomitant respiratory failure primarily due to another process requiring a different pathway.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

HFNC group

Experimental group

Description:

Included patients in this arm will exposed to HFNC as a modality for ventilatory support for patients with pulmonary embolism admitted to RICU.

Treatment:

Device: High-Flow Nasal Cannula (HFNC)

NIV group

Experimental group

Description:

Included patients in this arm will exposed to NIV as a modality for ventilatory support for patients with pulmonary embolism admitted to RICU.

Treatment:

Device: Non-Invasive Ventilation (NIV)