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

January 25, 2026 updated by: Montaser Gamal Ahmed, Assiut University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • أسيوط - Asyut Governorate
      • Asyut, أسيوط - Asyut Governorate, Egypt, 71511
        • Assiut university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HFNC group
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)
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%).
Experimental: NIV group
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weaning success at 48 h
Time Frame: 48 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: montaser G ahmed, phD, Department of Chest Diseases, Assiut University Hospitals, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria

January 25, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 25, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFNCvs NIV in PE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe