Evaluation of Dyspnea, Pulmonary VentIlation and DIaphragmatic Function in de Novo Adult Acute Respiratory Failure.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Oro-tracheal intubation
研究概览
简要总结
Modern management of acute respiratory failure aims to relieve dyspnea and anxiety by providing a non-invasive respiratory support. This approach tries to avoid endotracheal intubation, patient self inflicted lung injuries (PSILI) and diaphragmatic dysfunction. The present study aims to evaluate dyspnea, pulmonary regional ventilation and diaphragmatic function in patients with hypoxemic acute respiratory failure by different observations, and to bring risk factor for intubation out.
详细描述
Patients aged of 18 years or more, presenting with an acute respiratory failure without hypercapnia will be included in the study. Clinical and biological variables, dyspnea assessment, regional lung ventilation (electrical impedance tomography) and diaphragm function (ultrasound) will be evaluated at inclusion and at 2 hours, 4 hours and 48 hours after inclusion. In case of intubation, diaphragmatic function will be also evaluated with phrenic nerve stimulation technique.
Primary endpoint is intubation at day 7. Secondary endpoints are measurement of dyspnea, pulmonary ventilation and diaphragmatic function, also ventilator free days, ICU length of stay and mortality.
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
- •Age > 18
- •Acute respiratory insufficiency defined by the three following items :
- •PaO2/ FiO2 <300
- •Respiratory rate > 25/min
- •Oxygen support > 10L/min or High Flow nasal oxygen (HFNO)
- •Non opposition by the patient to be included
- •Social insurance
排除标准
- •Respiratory acidosis (pH < 7,35 PaCO2 > 45mmHg or 6kPa)
- •Chronic respiratory disease ( COPD, bronchiectasis…)
- •Cardiogenic Acute lung oedema
- •Non intubation decision at randomisation
- •Contraindication for Electro-impedance tomography-belt placement (chest trauma with rib fractures, thoracic wound, chest tube).
- •Uncommunicative patient (Glasgow coma scale <12)
- •Guardianship or curators for vulnerable patients.
研究组 & 干预措施
Patients with de novo acute respiratory failure
The following tests will be performed as part of the research (these tests are usually performed as part of routine care but not routinely and comprehensively):
- A diaphragmatic ultrasound in the half-seated position. Diaphragmatic excursion and thickening fraction will be measured in the right hemi-diaphragm.
- A 10-minute reference acquisition. They will be performed at inclusion, H2, H4 and H48.
干预措施: Diaphragmatic ultrasound and electrical impedance tomography (Other)
结局指标
主要结局
Oro-tracheal intubation
时间窗: 7 days after admission in the ICU
Patients who will be intubated within the 7 days after admission in the ICU
次要结局
- Mechanical ventilation duration(28 days after inclusion)
- ICU length of stay(28 days after inclusion)
- lung regional ventilation(2 days after inclusion)
- ICU mortality(28 days after inclusion)
- Diaphragmatic function(2 days after inclusion)
- Dyspnea evaluation(28 days after inclusion)