跳至主要内容
临床试验/NCT07381712
NCT07381712
进行中(未招募)
不适用

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

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月1日最近更新:

概览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Weaning success at 48 h

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: High-Flow Nasal Cannula (HFNC) (Device)

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.

干预措施: Non-Invasive Ventilation (NIV) (Device)

结局指标

主要结局

Weaning success at 48 h

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Montaser Gamal Ahmed

lecturer

Assiut University

研究点 (1)

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