Predictive Value of Diaphragmatic Excursion by Echographic Assessment at the Bedside on Need for Endotracheal Intubation in COPD Patients With Acute Dyspnea in Emergency Medicine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 390
- 试验地点
- 3
- 主要终点
- Evaluate the predictive value of the presence of diaphragmatic dysfunction diagnosed by ultrasound measurement of the diaphragmatic excursion (ED) on the use of invasive mechanical ventilation (IV)
研究概览
简要总结
The investigators seek to evaluate if the ultra-sound measure of the diaphragm expansion is predictive of admission into an ICU and/or intubation for patients with COPD.
Every patient coming to the ER with shortness of breath and a known or suspected COPD, will undergo standard of care associated with a diaphragm ultrasound.
The investigators will then gather, through the internal databases of the recruiting hospitals, information about admission into ICU and/or intubation.
The investigators think that this technique will help improve early detection of COPD patient requiring mechanical ventilation, using ultrasound, a non invasive technique.
详细描述
Inclusion of every lawful age patient presenting to the ER with inclusion criterias
The patient must not have exclusion criteria and must have received the information and consent sheets to be signed jointly
Then, the investigators perform an online randomization for the first and second operator and the side (left/right) from which they start the ultrasound assessment.
The investigators then assess diaphragmatic excursion measurements in spontaneously ventilated patient at 45 ° proclive position for each hemi-diaphragm, with the 2 operators blinded to each other, for 3 consecutive respiratory cycles and save the images.
The date of inclusion is then reported in the register.
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
- 否
入选标准
- •Spontaneous ventilation at arrival to the ER
- •With Respiratory Failure defined by at least of the following criterias :
- •Respiratory frequency > 25 and/or clinical signs of respiratory failure
- •Hypoxia with a WpO2 < 90%
- •Hypercapnia > 45mmHg with a respiratory acidosis
排除标准
- •Known diaphragmatic dysfunction
- •Necessity of immediate intubation leaving no time for ultrasound measurements of diaphragmatic excursion
- •Unable to provide informed consent
- •Evolutive or degenerative neurological disease that could affect diaphragmatic function
- •Intracranial Hypertension
- •Haemodynamic instability
- •Acute heart failure
- •Pregnant or Breastfeeding
结局指标
主要结局
Evaluate the predictive value of the presence of diaphragmatic dysfunction diagnosed by ultrasound measurement of the diaphragmatic excursion (ED) on the use of invasive mechanical ventilation (IV)
时间窗: During the 24 first hours after admission to the ED
predictive value of the presence of a diaphragmatic dysfunction on the use of invasive mechanical ventilation (IV)
次要结局
- Find a correlation between length of stay, length of ventilation, respiratory complications and the values of ED and E-T index measured at patient admission(Through study completion, an average of 2 years)
- Assessment of staff learning curves senior and junior medical staff participating in initial training.(Through study completion, an average of 2 years)
- Evaluate the predictive value of the ultrasound measurement of the E-T index for the use of invasive ventilation E-T index (IET) on the use of mechanical ventilation invasive(During the first 24 hours after admission to ED)
- Assess the inter-observer feasibility and reproducibility of the measurement of ED and IET measured by ultrasound in time-movement mode (TM)(Through study completion, an average of 2 years)
研究者
Matthieu Daniel
Head of Clinic - Intensive Care Unit
European Georges Pompidou Hospital