Correlation Between Tidal Volume in Spontaneous Ventilation and Tidal Volume in Non-invasive Ventilation in Acute Hypoxemic Non-hypercapnic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Show a correlation between the tidal volume measurement in spontaneous ventilation and the tidal volume measurement in NIV
研究概览
简要总结
The diagnosis of Acute Respiratory Distress Syndrome (ARDS) is a syndromic diagnosis that groups together patients who may have very different prognoses and respond differently to the same therapies.
Additionally, non-invasive ventilation (NIV) has shown highly contrasting results in the early management of ARDS. One of the predictive criteria for NIV failure is an excessively high tidal volume during non-invasive ventilation.
SPIRALI is a pilot study evaluating the relevance of a respiratory physiology parameter, the tidal volume relative to the theoretical ideal body weigh, in the phenotypic classification of non-intubated ARDS patients. In this initial approach, the investigators will compare the tidal volume during high-flow oxygen therapy with the tidal volume obtained under NIV (after applying a settings optimization algorithm). The investigators hypothesize that if tidal volume is linked to each situation, the same patients will exhibit a high tidal volume both during spontaneous ventilation and under NIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Patient over 18 years of age;
- •Patient hospitalized in intensive care for less than 24 hours;
- •Patient with severe hypoxemic acute respiratory failure characterized by a PaO2/FiO2 ratio < 300 mmHg and > 150 mmHg under high-flow oxygen therapy at 60 L/min;
- •Patient able to cooperate with the spirometry test;
- •Patient able to follow the protocol and having given their informed written consent to participate in the study;
- •Patient affiliated with the social security system or entitled to benefits;
排除标准
- •Patients with an indication for intubation;
- •Patients with a contraindication for or who refuse NIV;
- •Patients with hemodynamic instability requiring vasopressor support greater than 0.25 μg/kg/min of norepinephrine;
- •Patients with a Glasgow score < 15;
- •Patients with hypercapnia (PaCO2 > 45 mmHg);
- •Patients with a PaO2/FiO2 ratio < 150 mmHg;
- •Patients with cardiogenic pulmonary edema;
- •Patients who have already undergone a session of NIV in intensive care during this stay;
- •Patients with chronic respiratory failure (home oxygen therapy or home non-invasive ventilation (excluding indications solely for sleep apnea syndrome));
- •Patients who have recently had a pneumothorax;
- •Patients who have recently undergone eye surgery (e.g., cataract surgery) or throat surgery;
- •Patients with significant arterial disease: recent heart attack, pulmonary embolism, poorly controlled hypertension despite treatment, etc.
- •Patients already included in the study;
- •Pregnant women, women in labor, or women who are breastfeeding;
- •Patients under guardianship, conservatorship, or deprived of their liberty;
- •Patients under an activated future protection mandate;
- •Patients under family authorization;
- •Patients under judicial protection;
研究组 & 干预措施
tidal volume in spontaneous ventilation and NIV
干预措施: Hand-held spirometer (Device)
tidal volume in spontaneous ventilation and NIV
干预措施: NIV (Device)
结局指标
主要结局
Show a correlation between the tidal volume measurement in spontaneous ventilation and the tidal volume measurement in NIV
时间窗: At T2 and T3, with measurement of VT using a portable spirometer and NIV on the day of enrollment. T1,T2,T3<1h30min
Tidal volume measured by a hand-held spirometer in spontaneous ventilation and exhaled tidal volume measured by the ventilator in NIV after optimization of the settings
次要结局
未报告次要终点