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

NCT07381712 | Active Not Recruiting

• 1 other identifier: HFNCvs NIV in PE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Embolism

Keywords

NIV,HFNC

Outcome Measures

Primary Outcomes (1)

• Weaning success at 48 h

  the ability of the patient to maintain spontaneous breathing without the need for reintubation, escalation to invasive mechanical ventilation, or initiation of rescue non-invasive ventilation within 48 hours. Patients who remained clinically stable, with acceptable gas exchange and no signs of respiratory failure during this period, were considered to have achieved weaning success.

  48 hours

Study Arms (2)

HFNC group

EXPERIMENTAL

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

Device: High-Flow Nasal Cannula (HFNC)

NIV group

EXPERIMENTAL

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

Device: Non-Invasive Ventilation (NIV)

Interventions

High-Flow Nasal Cannula (HFNC) DEVICE

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%).

HFNC group

Non-Invasive Ventilation (NIV) DEVICE

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.

NIV group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. Age ≥18 y; presented with acute PE confirmed by CTPA or high-probability V/Q.
• \. AHRF needing non-invasive support; provided that patients able to protect airway and hemodynamically stable without escalating vasopressors

You may not qualify if:

• \. Immediate indication for intubation; high-risk (massive) PE with shock requiring advanced airway/vasopressors; active major bleeding; untreated pneumothorax.
• \. Contraindications/intolerance to assigned modality (e.g., facial trauma for NIV; complete nasal obstruction for HFNC).
• \. Do-Not-Intubate orders; pregnancy ; concomitant respiratory failure primarily due to another process requiring a different pathway.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospitals

Asyut, أسيوط - Asyut Governorate, 71511, Egypt

Location

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• montaser G ahmed, phD

  Department of Chest Diseases, Assiut University Hospitals, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 2, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)