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临床试验/NCT05342103
NCT05342103已完成不适用

High Flow Nasal Oxygenation Versus Non-invasive Ventilation for Patients With Blunt Chest Trauma: A Comparative Study

Huda Fahmy Mahmoud, PhD2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
the rate of intubation for mechanical ventilation

研究概览

简要总结

Chest trauma remains an issue for health services for both severe and apparently mild trauma management. Severe chest trauma is associated with high mortality and is liable for 25% of mortality in multiple traumas. Moreover, mild trauma is also associated with significant morbidity, especially in patients with preexisting conditions. Thus, whatever the severity, a fast-acting strategy must be organized. In order to improve the prognosis of patients with severe chest trauma, early and continuous application of non-invasive mechanical ventilation (NIV) can indeed reduce the need for intubation and shorten intensive care unit length-of-stay. Among different mechanisms, the early use of positive end-expiratory pressure after chest trauma, when feasible, seems mandatory to optimize oxygenation and improve clinical outcomes. Indeed, interventions aimed at preventing ARDS after chest trauma carry the greatest potential to reduce the substantial morbidity, mortality, and resource utilization associated with this syndrome.

详细描述

In the past years, High-flow nasal cannula oxygen (HFNC) has gained an important popularity among intensivest to manage patients with acute respiratory failure, filling a gap in the ventilatory support escalation between facemask oxygen and non-invasive or invasive mechanical ventilation. Interestingly, the use of HFNC was widely and rapidly adopted in ICUs.A unique feature of HFNC is its ability to comfortably deliver high flows of warmed humidified gas, 20-70 L min, with a FiO2 range of 0.21-1.0. Physiological responses to HFNC therapy include increases in airway pressure, end-expiratory lung volume (EELV), and oxygenation which are probably optimal with higher flows (60-70 L/min), while the effects on dead-space washout work of breathing, and respiratory rate may be obtained with intermediate flows (20-45 L/min).

Many studies have found that high flow nasal oxygen is much better tolerated by patients compared to non-invasive ventilation, which may improve compliance. Nevertheless, there is no clear consensus on the treatment outcomes (such as intubation rate, escalated respiratory support rate, and mortality) of high flow nasal oxygenation versus non-invasive ventilation for patients with traumatic chest injuries.

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
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Rib fractures, pulmonary contusion, and admission within 24 h of injury
  • Hypoxemia (SpO2 90 % while breathing 10 l/min oxygen in the ER), or hypercapnia (PaCO2 45 mm Hg) on study entry
  • respiratory rate 25/ min despite an optimized intravenous analgesia
  • No indication of mechanical ventilation at the time of admission to the intensive care unit

排除标准

  • Patients < 18 years old
  • Patient already admitted to ICU on mechanical ventilation
  • requiring endotracheal intubation and mechanical ventilation immediately on admission for any cause
  • facial fractures or base of skull fractures
  • Who did not receive a chest computed tomography (CT) scan
  • Glasgow Coma Scale ≤ 12

结局指标

主要结局

the rate of intubation for mechanical ventilation

时间窗: 48 hours

Intubation criteria included a respiratory rate of \>40 breaths per minute, signs of increased breathing effort, SpO2 of \<90% despite high FiO2 or acidosis with a pH of \<7.35,occurrence of hemodynamic instability or deterioration of neurologic status.

次要结局

  • the Comfort levels with the different modes of oxygen delivery(48 hours)
  • the perceived effort of breathing with the different modes of oxygen delivery(48 hours)

研究者

发起方
Huda Fahmy Mahmoud, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Huda Fahmy Mahmoud, PhD

Assistant professor of Anesthesia and Intensive Care

Aswan University Hospital

研究点 (2)

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