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临床试验/NCT05869045
NCT05869045尚未招募不适用

The Impact of Point-of-care Ultrasound (POCUS) on the Prognosis of Respiratory Failure in Patients Presenting to the Emergency Department Based on Diaphragmatic Dysfunction

Azienda Ospedaliero-Universitaria di Modena0 个研究点目标入组 432 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
432
主要终点
Composite of mortality, intubation, or noninvasive ventilation failure within 30 days of admission

研究概览

简要总结

This study aims to evaluate the use of POCUS to assess diaphragmatic function and its association with clinical outcomes in patients with respiratory failure who are admitted to the emergency department.

详细描述

Respiratory failure is a common condition that requires prompt diagnosis and treatment in the emergency department. Diaphragmatic dysfunction (DD) is a potential contributor to respiratory failure, but it is often underdiagnosed and undertreated. Point-of-care ultrasound (POCUS) is a non-invasive and feasible tool that can measure diaphragmatic function using parameters such as diaphragm excursion and diaphragm shortening fraction (DSF). However, the prognostic value of POCUS for DD in patients with respiratory failure is unclear.

This study is a prospective observational cohort study that will enroll consecutive patients with respiratory failure who are admitted to the emergency department of a tertiary hospital. All patients will undergo POCUS examination of the diaphragm within 6 hours of admission by trained emergency physicians. The primary outcome will be the composite of mortality, intubation, or noninvasive ventilation failure within 30 days of admission. The secondary outcomes will include length of hospital stay, intensive care unit admission, and ventilator-free days. The association between POCUS parameters of diaphragmatic function and clinical outcomes will be analyzed using multivariate logistic regression and Cox proportional hazards models.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Respiratory failure defined as one or more of the following: respiratory rate >24 breaths/min, oxygen saturation <90% on room air, PaO2/FiO2 ratio <300 mmHg, or need for supplemental oxygen
  • Ability to provide informed consent or availability of a legal representative

排除标准

  • Pregnancy
  • History of thoracic surgery or trauma
  • Known neuromuscular disease affecting the diaphragm
  • Contraindications for POCUS examination such as chest wall deformity, subcutaneous emphysema, or skin infection

结局指标

主要结局

Composite of mortality, intubation, or noninvasive ventilation failure within 30 days of admission

时间窗: Patients will be followed up for a maximum of 1 months from admission to the emergency department, until discharge or death

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

Carmine Cristiano Di Gioia

Attending physician

Azienda Ospedaliero-Universitaria di Modena

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