Analysis of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department: Predicting Respiratory Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 3
- 主要终点
- Measurement of diaphragmatic excursion by M-mode ultrasound
研究概览
简要总结
The main objective of this study is to show that "diaphragmatic excursion measures upon emergency admission" (CDA values) on patients with acute respiratory failure are predictive of the need to use mechanical ventilation (invasive or non-) in the first four hours.
详细描述
The secondary objectives of this study are:
A-determine a prognostic threshold for diaphragmatic excursion measures able to predict the use of mechanical ventilation (invasive or not) in the first four hours.
B-to study the association between CDA values and persistence of respiratory distress during the first 4 hours of care among patients who, at 4 hours, are not mechanically ventilated.
C-to study the association between CDA values and respiratory re-exacerbation or a continuing need for mechanical ventilation during the 24 first hours after admission to the emergency room D-to study the association between diaphragmatic excursion measures made after initial emergency care (at 4 hours; =CDH4), and the persistence of respiratory distress at 4 hours, in patients who at 4 hours are not mechanically ventilated.
E-to study the association between CDH4 values and respiratory re-exacerbation during the 24 first hours after admission to the emergency room among patients who, at 4 hours, are not mechanically ventilated F-to study the association between changes in values of diaphragmatic excursion measure before and after initial emergency care (CDA → CDH4) and respiratory re-exacerbation during the 24 first hours after admission to the emergency room among patients who, at 4 hours, are not mechanically ventilated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has given informed consent (and signed the consent form) or, in case of an emergency situation, an investigator has committed to obtaining the consent of the patient as soon as his/her condition permits
- •Patient affiliated with or beneficiary of a health insurance plan
- •Acute Respiratory Distress (DRA) defined by: (1) respiratory rate > 25 and/or signs of struggle and hypoxia AND (2) SpO2 values < 90% and/or [pH < 7.35 and pCO2 > 6 kPa (45 mm Hg)]
- •Breathing spontaneously (no ventilation)
排除标准
- •Patient currently participating in or having participated in another interventional study in the previous three months, or patient in an exclusion period determined by a previous study
- •Patient under judicial protection or any kind of guardianship
- •Refusal to sign the consent
- •Patient pregnant, parturient, or lactating
- •Neurological or neuromuscular disease modifying the operation of the diaphragm without any decompensation (Polyneuropathy, Lou Gehrig's disease, Myasthenia ...)
- •Patient who received mechanical ventilation at home
- •Patient who received treatment by mechanical ventilation during the pre-hospitalization care phase
- •Patient admitted with respiratory failure requiring immediate installation of a mechanical ventilation and thus not allowing the performance of two ultrasound measurements
- •Patient suffering from a pneumothorax
研究组 & 干预措施
Prognostic study population
The study population consists of patients treated for acute respiratory distress in the emergency department at the Nîmes University Hospital. See inclusion and exclusion criteria.
Intervention: Diaphragmatic ultrasound
干预措施: Vivid S6 GE Ultrasound (Device)
结局指标
主要结局
Measurement of diaphragmatic excursion by M-mode ultrasound
时间窗: Day 0, baseline
in centimeters
Use of ventilation within the first 4 hours
时间窗: Day 0, baseline + 4 hours
yes/no
次要结局
- Measurement of diaphragmatic excursion by M-mode ultrasound(Day 0, baseline + 4 hours)
- Acute respiratory distress signs within the first 4 hours(Day 0, baseline + 4 hours)
- Signs of respiratory re aggravation at 24 hours(Day 1)
- Diagnosis(Day 1)